A Study of the Drugs AGN-242428 and AGN-231868 in Partici... | NCT04030962 | Trialant
NCT04030962
Sponsor
AbbVie
Status
Completed
Last Update Posted
May 20, 2025Actual
Enrollment
292Actual
Phase
Phase 1Phase 2
Conditions
Dry Eye Disease
Dry Eye Syndrome
Interventions
AGN-242428
AGN-231868
AGN-242428 Vehicle
AGN-231868 Vehicle
Lifitegrast 5% Ophthalmic Solution
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT04030962
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
2012-201-005
Secondary IDs
Not provided
Brief Title
A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
Official Title
A Multicenter, Vehicle-controlled, Double-Masked, Randomized Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
Acronym
Not provided
Organization
AbbVieINDUSTRY
Status Module
Record Verification Date
May 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Mar 4, 2020Actual
Primary Completion Date
Mar 18, 2022Actual
Completion Date
Mar 18, 2022Actual
First Submitted Date
Jul 10, 2019
First Submission Date that Met QC Criteria
Jul 22, 2019
First Posted Date
Jul 24, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Feb 13, 2025
Results First Submitted that Met QC Criteria
May 16, 2025
Results First Posted Date
May 20, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 16, 2023
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
May 20, 2025Actual
Last Update Submitted Date
May 16, 2025
Last Update Posted Date
May 20, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
AbbVieINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This was a 2-stage study in which Stage 1 evaluated the safety of AGN-242428 and AGN-231868, how well they are tolerated, and how they move through the body when administered. After the sponsor's determination of adequate safety and tolerability of the interventions in Stage 1, Stage 2 began. Stage 2 also evaluated the safety and tolerability of AGN-242428 and AGN-231868, how effective they are in treating dry eye disease (DED), and assessed the plasma and tear exposure of both ophthalmic solutions.
Detailed Description
Participants with DED in Cohort 1A were randomized 3:3:1:1 to receive AGN-242428 (Low Dose), AGN-231868 (Low Dose), or their respective vehicles (4 treatment groups total) to the left eye on Day 1 (Visit 2). If there were no significant study drug-related safety findings, starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single dose administration to both eyes on Day 15 (Visit 5).
Upon completion of Cohort 1A, an independent data monitoring committee reviewed the data before proceeding to the next cohort. Cohort 1B participants were randomized 3:3:1:1 to receive AGN-242428 (High Dose), AGN-231868 (High Dose), or their respective vehicles (4 treatment groups total) and followed the same dosing regimen used in Cohort 1A.
All subjects enrolled in Stage 2 had DED. In addition, subjects were selected based on their response to a controlled adverse environment (CAE). Only subjects with DED who responded to the CAE exposure with an increase in the signs and symptoms of DED were enrolled in Stage 2.
During Stage 2, participants were randomized in a 1:1:1:1:1 ratio (within each site), to receive AGN-242428 (High Dose), AGN-242428 vehicle, AGN-231868 (High Dose), AGN-231868 vehicle, or Lifitegrast Ophthalmic Solution (Xiidra). Participants administered the assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Conditions Module
Conditions
Dry Eye Disease
Dry Eye Syndrome
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 1Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
292Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1 Cohort 1A: AGN-242428 Low Dose
Experimental
Administration of AGN-242428 ophthalmic solution
Drug: AGN-242428
Stage 1 Cohort 1A: AGN-242428 Vehicle
Placebo Comparator
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-242428 Vehicle
Stage 1 Cohort 1A: AGN-231868 Lose Dose
Experimental
Administration of AGN-231868 ophthalmic solution
Drug: AGN-231868
Stage 1 Cohort 1A: AGN-231868 Vehicle
Placebo Comparator
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-231868 Vehicle
Stage 1 Cohort 1B: AGN-242428 High Dose
Experimental
Administration of AGN-242428 ophthalmic solution
Drug: AGN-242428
Stage 1 Cohort 1B: AGN-242428 Vehicle
Placebo Comparator
Interventions
Name
Type
Description
Arm Group Labels
Other Names
AGN-242428
Drug
Ophthalmic solution administered as a topical eye drop
Stage 1 Cohort 1A: AGN-242428 Low Dose
Stage 1 Cohort 1B: AGN-242428 High Dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Stage 1: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Day 1 to Day 15
Stage 1: Area Under the Plasma Concentration Versus Time Curves After Single and Repeat Dose Administration
Following single dose administration, the area under the plasma concentration versus time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the plasma concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Area Under the Tear Concentration Versus Time Curves After Single and Repeat Dose Administration
Following single dose administration, the area under the tear concentration versus (vs) time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the tear concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Maximum Plasma Drug Concentration (Cmax) After Single and Repeat Dose Administration
Following single dose administration, the plasma Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Cmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Secondary Outcomes
Measure
Description
Time Frame
Stage 2: Trough Plasma Concentration (Ctrough) and Plasma Concentration at 0.5 Hours Postdose (C0.5h)
Trough plasma concentration (Ctrough) and plasma concentration at 0.5 hours postdose (C0.5h), following twice daily dosing for up to 6 weeks
Day 42
Stage 2: Trough Tear Concentration (Ctrough) and Tear Concentration at 0.5 Hours Postdose (C0.5h)
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Stage 1 & Stage 2:
Male participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study.
Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
Stage 1:
Both of the following signs of DED in at least 1 eye at Screening and Baseline visits (the same eye does not need to qualify at both visits):
Total corneal fluorescein staining score ≥ 2 and ≤ 9 based on the NEI grading scale, with no score > 2 in any 1 region;
Schirmer test with topical anesthesia score ≥ 1 and ≤ 10 mm/5 min.
Stage 2:
ALL of the following in at least 1 eye at both the Screening and Baseline visits and the same eye must qualify at both Screening and Baseline visits:
Corneal fluorescein staining score ≥ 2 in at least 1 eye region and a total corneal fluorescein staining score of ≥ 4 and ≤ 12 based on NEI grading scale;
Schirmer test with topical anesthesia score ≥ 2 and ≤ 10 mm/5 min;
Mean TBUT of ≥ 2 and ≤ 10 seconds.
Stage 1:
- Symptoms of DED at both the Screening and Baseline visits as defined by an OSDI total score of ≥ 13 with ≤ 3 responses of "not applicable (NA)."
Stage 2:
Symptoms of DED at both the Screening and Baseline visits as defined by both:
OSDI score of ≥ 23 with ≤ 3 responses of "not applicable (NA)" in at least 1 eye;
Eye Dryness Score (assessed using the Visual Analog Scale [VAS] Symptom Items score ≥ 30).
Exclusion Criteria:
Current diagnosis of glaucoma or ocular hypertension; evidence of glaucoma or mean intraocular pressure > 21 mm Hg determined by Goldmann applanation tonometry, in either eye.
Diagnosis of recurrent, ongoing, or active ocular infection including, but not limited to herpes simplex or zoster, vaccinia, varicella, tuberculosis of the eye, acanthamoeba, or fungal disease.
Participation in a blood or plasma donation program within 60 or 30 days, respectively, prior to study intervention administration.
Positive test results for anti-HIV type 1 and 2, hepatitis B surface antigen, or anti-hepatitis C virus at the Screening visit.
Positive test results for benzoylecgonine (cocaine), methadone, barbiturates, amphetamines, benzodiazepines, alcohol, cannabinoids, opiates, or phencyclidine at the Screening or Baseline visits.
Positive pregnancy test at Screening or Baseline visits.
Currently breastfeeding or plans to breastfeed during the study.
History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or participant safety.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
ABBVIE INC.
AbbVie
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Cornea and Cataract Consultants of Arizona /ID# 232769
Phoenix
Arizona
85032
United States
The Eye Research Foundation /ID# 232696
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
For details on when studies are available for sharing, please refer to the link below.
Access Criteria
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
All safety analyses were performed on the safety population, which included all randomized participants who received at least 1 administration of study intervention (Stage 1, n=48; Stage 2, n=244). The pharmacokinetic population (Stage 1) included all participants with evaluable PK parameters in Stage 1. The pharmacokinetic population (Stage 2) included all participants with available plasma or tear concentrations in Stage 2.
Recruitment Details
In Stage 1, 48 participants at 2 sites in the US were randomized and treated (24 participants each in Cohorts 1A and 1B). In Stage 2, 244 subjects at 10 sites in the US were randomized and treated (49 subjects each in the AGN-242428 (High Dose), AGN-242428 vehicle, and AGN-231868 vehicle groups; 47 subjects in the AGN-231868 (High Dose); and 50 subjects in the Xiidra 5% group).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG001
Periods
Title
Milestones
Reasons Not Completed
Stage 1
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Jul 14, 2021
Jan 21, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-242428 Vehicle
Stage 1 Cohort 1B: AGN-231868 High Dose
Experimental
Administration of AGN-231868 ophthalmic solution
Drug: AGN-231868
Stage 1 Cohort 1B: AGN-231868 Vehicle
Placebo Comparator
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-231868 Vehicle
Stage 2 Cohort 2: AGN-242428 High Dose
Experimental
Administration of AGN-242428 ophthalmic solution
Drug: AGN-242428
Stage 2 Cohort 2: AGN-242428 Vehicle
Placebo Comparator
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-242428 Vehicle
Stage 2 Cohort 2: AGN-231868 High Dose
Experimental
Administration of AGN-231868 ophthalmic solution
Drug: AGN-231868
Stage 2 Cohort 2: AGN-231868 Vehicle
Placebo Comparator
Administration of matching placebo (vehicle) ophthalmic solution
Other: AGN-231868 Vehicle
Stage 2 Cohort 2: Lifitegrast Ophthalmic Solution
Active Comparator
Administration of Lifitegrast ophthalmic solution
Drug: Lifitegrast 5% Ophthalmic Solution
Stage 2 Cohort 2: AGN-242428 High Dose
AGN-231868
Drug
Ophthalmic solution administered as a topical eye drop
Stage 1 Cohort 1A: AGN-231868 Lose Dose
Stage 1 Cohort 1B: AGN-231868 High Dose
Stage 2 Cohort 2: AGN-231868 High Dose
AGN-242428 Vehicle
Other
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
Stage 1 Cohort 1A: AGN-242428 Vehicle
Stage 1 Cohort 1B: AGN-242428 Vehicle
Stage 2 Cohort 2: AGN-242428 Vehicle
AGN-231868 Vehicle
Other
Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
Stage 1 Cohort 1A: AGN-231868 Vehicle
Stage 1 Cohort 1B: AGN-231868 Vehicle
Stage 2 Cohort 2: AGN-231868 Vehicle
Lifitegrast 5% Ophthalmic Solution
Drug
Ophthalmic solution administered as a topical eye drop
Stage 2 Cohort 2: Lifitegrast Ophthalmic Solution
Xiidra
Stage 1: Maximum Tear Drug Concentration (Cmax) After Single and Repeat Dose Administration
Following single dose administration, the tear Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Cmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Time of Maximum Plasma Drug Concentration (Tmax) After Single and Repeat Dose Administration
Following single dose administration, the plasma Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Tmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Time of Maximum Tear Drug Concentration (Tmax) After Single and Repeat Dose Administration
Following single dose administration, the tear Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Tmax (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Single Dose Administration
Following single dose administration, the plasma T1/2 (Day 2; Visit 3) was calculated.
Day 2 (Predose and up to 12 hours postdose).
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, plasma T1/2 (Day 15; Visit 5) was calculated.
Day 15 (Predose and up to 12 hours postdose)
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Tear After Single and Repeat Dose Administration
Following single dose administration, the tear T1/2 (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, tear T1/2 (Visit 5) was calculated.
Day 2 and Day 15 (Predose and up to 12 hours postdose)
Stage 1: Minimum Tear Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, the tear Cmin,ss (Visit 5) was calculated.
Day 15 (Predose and up to 12 hours postdose)
Stage 1: Minimum Plasma Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, the plasma Cmin,ss (Visit 5) was calculated.
Day 15 (Predose and up to 12 hours postdose)
Stage 1: Mean Accumulation Index of Drug Concentration (AI) After Repeat Dose Administration
Following repeat dose administration, the mean plasma and tear AI(area under curve [AUC]) was calculated. AI(AUC) is reported as the ratio of exposure (AUC) at steady state (Day 15) to the exposure after a single daily dose (Day 1). Values greater than one are indicative of drug accumulation with repeat dosing.
Day 15 (up to 12 hours) / Day 1 (up to 12 hours)
Stage 1: Mean Drop Tolerability Questionnaire Scores
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Day 15
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
The percentage of participants with non-PCS baseline value and met PCS criterion at least once postbaseline for clinical laboratory values.
Day 1 to Day 15
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature)
Day 1 to Day 15
Stage 1: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
The percentage of participants with PCS postbaseline (but not at baseline) ECG values for QRS interval, PR interval, and QTc (Fridericia)
Day 1 to Day 15
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
At least 2 measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated.
Day 1 to Day 15
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol.
Day 1 to Day 15
Stage 1: Biomicroscopy: Percentage of Participants With Any Severity Increase From Baseline
The number of participants with any ophthalmoscopy findings of any severity increase from baseline at one or more visit.
Day 1 to Day 15
Stage 1: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Day 1 to Day 15
Stage 2: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Day 1 to Day 42
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
The percentage of participants who have PCS postbaseline clinical laboratory values at Day 42 (Visit 6).
Day 42
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values at Day 42 (Visit 6) (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Day 42
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
The percentage of participants who have PCS ECG at Visit 6 (but not baseline) pre and post-controlled adverse environment (CAE). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Day 42
Stage 2: Mean Change From Baseline in Intraocular Pressure (IOP)
At least 2 IOP measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated. Average intraocular pressure = mean of the 2 (or 3) measures in the study eye and non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Day 1, Day 42
Stage 2: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol in the study eye and the non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Day 1, Day 42
Stage 2: Slit-lamp Biomicroscopy: Percentage of Participants With Any Clinically Significant Finding Postbaseline
Percentage of participants with a clinically significant finding postbaseline, post-CAE. A clinically significant finding is defined as more than one severity grade increase (worsening) from baseline or positive status change from absence at baseline to presence at postbaseline (not associated with a severity grade) in one or both eyes.
Day 1 to Day 42
Stage 2: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Day 1 to Day 42
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Participants completed questionnaires after exposure to a controlled adverse environment (CAE) for approximately 90 minutes. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Day 42 (Post-CAE)
Trough tear concentration (Ctrough) and tear concentration at 0.5 hours postdose (C0.5h), following twice daily dosing for up to 6 weeks
Day 42
Newport Beach
California
92663-3637
United States
Vision Institute Central /ID# 239910
Colorado Springs
Colorado
80907-7529
United States
The Eye Care Institute /ID# 232683
Louisville
Kentucky
40206
United States
Andover Eye Associates /ID# 232689
Andover
Massachusetts
01810
United States
Vita Eye Clinic /ID# 232721
Shelby
North Carolina
28150
United States
Scott and Christie and Associates /ID# 232746
Cranberry Township
Pennsylvania
16066
United States
Total Eye Care, PA /ID# 232657
Memphis
Tennessee
38119-5745
United States
Advancing Vision Research /ID# 232660
Smyrna
Tennessee
37167
United States
Duplicate_Alpine Research Organization, Inc. /ID# 240508
Clinton
Utah
84015-8562
United States
Piedmont Eye Center /ID# 232698
Lynchburg
Virginia
24502
United States
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
FG008
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
FG009
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
FG010
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
FG011
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
FG0009 subjects
FG0013 subjects
FG0029 subjects
FG0033 subjects
FG0049 subjects
FG0053 subjects
FG0069 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
COMPLETED
FG0009 subjects
FG0013 subjects
FG0029 subjects
FG0033 subjects
FG0049 subjects
FG0053 subjects
FG0069 subjects
FG0073 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
Stage 2
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG00849 subjects
FG00949 subjects
FG01047 subjects
FG01149 subjects
FG01250 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Safety Population (N=292)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
BG008
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
BG009
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
BG010
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
BG011
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
BG013
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG0013
BG0029
BG0033
BG0049
BG0053
BG0069
BG0073
BG00849
BG00949
BG01047
BG01149
BG01250
BG013292
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00064.4± 10.82
BG00171.7± 8.02
BG00265.0± 8.47
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0005
BG0012
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0001
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Stage 1: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Safety population (Stage 1; N=48)
Posted
Count of Participants
Participants
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG003
Title
Denominators
Categories
Title
Measurements
OG0005
OG0011
OG0024
OG003
Primary
Stage 1: Area Under the Plasma Concentration Versus Time Curves After Single and Repeat Dose Administration
Following single dose administration, the area under the plasma concentration versus time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the plasma concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
PK Population (Stage 1; N=36).
Posted
Mean
Standard Deviation
pg•hr/mL
Day 2 and Day 15 (Predose and up to 12 hours postdose)
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Primary
Stage 1: Area Under the Tear Concentration Versus Time Curves After Single and Repeat Dose Administration
Following single dose administration, the area under the tear concentration versus (vs) time curves from time 0 to time of the last measurable concentration (AUC0-tlast; Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the area under the tear concentration versus time curves from time 0 to the end of the dosing interval (AUC0-τ; Visit 5) was calculated. For Visit 3 and Visit 5, tlast was 12 hours post-dose.
PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Posted
Mean
Standard Deviation
ng•hr/mL
Day 2 and Day 15 (Predose and up to 12 hours postdose)
eyes
eyes
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Maximum Plasma Drug Concentration (Cmax) After Single and Repeat Dose Administration
Following single dose administration, the plasma Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Cmax (Visit 5) was calculated.
PK Population (Stage 1; N=36).
Posted
Mean
Standard Deviation
pg/mL
Day 2 and Day 15 (Predose and up to 12 hours postdose)
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Maximum Tear Drug Concentration (Cmax) After Single and Repeat Dose Administration
Following single dose administration, the tear Cmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Cmax (Visit 5) was calculated.
PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Posted
Mean
Standard Deviation
ng/mL
Day 2 and Day 15 (Predose and up to 12 hours postdose)
eyes
eyes
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Primary
Stage 1: Time of Maximum Plasma Drug Concentration (Tmax) After Single and Repeat Dose Administration
Following single dose administration, the plasma Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the plasma Tmax (Visit 5) was calculated.
PK Population (Stage 1; N=36).
Posted
Median
Standard Deviation
hours
Day 2 and Day 15 (Predose and up to 12 hours postdose)
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Time of Maximum Tear Drug Concentration (Tmax) After Single and Repeat Dose Administration
Following single dose administration, the tear Tmax (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, the tear Tmax (Visit 5) was calculated.
PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Posted
Median
Standard Deviation
hours
Day 2 and Day 15 (Predose and up to 12 hours postdose)
eyes
eyes
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Primary
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Single Dose Administration
Following single dose administration, the plasma T1/2 (Day 2; Visit 3) was calculated.
PK Population (Stage 1; N=36). Data was available for all participants; however, T1/2 was reported only when Rsq_adjusted ≥ 0.8, per the planned analysis. Number Analyzed for each timepoint includes only those participants with Rsq_adjusted ≥ 0.8.
Posted
Mean
Standard Deviation
hours
Day 2 (Predose and up to 12 hours postdose).
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Primary
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Plasma After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, plasma T1/2 (Day 15; Visit 5) was calculated.
PK Population (Stage 1; N=36). Data was available for all participants; however, T1/2 was reported only when Rsq_adjusted ≥ 0.8, per the planned analysis. Number Analyzed for each timepoint includes only those participants with Rsq_adjusted ≥ 0.8.
Posted
Mean
Standard Deviation
hours
Day 15 (Predose and up to 12 hours postdose)
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Primary
Stage 1: Terminal Elimination Half-life of the Study Drugs (T1/2) in Tear After Single and Repeat Dose Administration
Following single dose administration, the tear T1/2 (Visit 3) was calculated. Following repeat dose administration twice daily for 14 days, tear T1/2 (Visit 5) was calculated.
PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'. Data was available for all participants; however, T1/2 was reported only when Rsq_adjusted ≥ 0.8, per the planned analysis. Number Analyzed for each timepoint includes only those participants with Rsq_adjusted ≥ 0.8.
Posted
Mean
Standard Deviation
hours
Day 2 and Day 15 (Predose and up to 12 hours postdose)
eyes
eyes
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Minimum Tear Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, the tear Cmin,ss (Visit 5) was calculated.
PK Population (Stage 1; N=36). Data were not combined for both eyes from each subject but were calculated as separate 'N'.
Posted
Mean
Standard Deviation
ng/mL
Day 15 (Predose and up to 12 hours postdose)
eyes
eyes
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Minimum Plasma Drug Concentration at Steady State (Cmin,ss) After Repeat Dose Administration
Following repeat dose administration twice daily for 14 days, the plasma Cmin,ss (Visit 5) was calculated.
PK Population (Stage 1; N=36).
Posted
Mean
Standard Deviation
pg/mL
Day 15 (Predose and up to 12 hours postdose)
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Mean Accumulation Index of Drug Concentration (AI) After Repeat Dose Administration
Following repeat dose administration, the mean plasma and tear AI(area under curve [AUC]) was calculated. AI(AUC) is reported as the ratio of exposure (AUC) at steady state (Day 15) to the exposure after a single daily dose (Day 1). Values greater than one are indicative of drug accumulation with repeat dosing.
PK Population (Stage 1; N=36).
Posted
Mean
Standard Deviation
ratio
Day 15 (up to 12 hours) / Day 1 (up to 12 hours)
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Primary
Stage 1: Mean Drop Tolerability Questionnaire Scores
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Safety Population
Posted
Mean
Standard Deviation
score on a scale
Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Percentage of Participants Who Met Criteria for Potentially Clinically Significant (PCS) Clinical Laboratory Values
The percentage of participants with non-PCS baseline value and met PCS criterion at least once postbaseline for clinical laboratory values.
Safety Population. Analysis included participants with a non-PCS baseline value and at least one post-baseline assessment.
Posted
Count of Participants
Participants
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature)
Safety Population
Posted
Count of Participants
Participants
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
The percentage of participants with PCS postbaseline (but not at baseline) ECG values for QRS interval, PR interval, and QTc (Fridericia)
Safety Population
Posted
Count of Participants
Participants
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Mean Change From Baseline in Intraocular Pressure (IOP)
At least 2 measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated.
Safety Population
Posted
Mean
Standard Deviation
mmHg
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol.
Safety Population
Posted
Mean
Standard Deviation
letters
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Biomicroscopy: Percentage of Participants With Any Severity Increase From Baseline
The number of participants with any ophthalmoscopy findings of any severity increase from baseline at one or more visit.
Safety Population
Posted
Count of Participants
Participants
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 1: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Safety Population
Posted
Count of Participants
Participants
Day 1 to Day 15
ID
Title
Description
OG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Primary
Stage 2: Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Safety Population
Posted
Count of Participants
Participants
Day 1 to Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG002
Stage 2 Cohort 2: AGN-231868 (High Dose)
Primary
Stage 2: Percentage of Participants With Potentially Clinically Significant (PCS) Clinical Laboratory Values
The percentage of participants who have PCS postbaseline clinical laboratory values at Day 42 (Visit 6).
Safety Population. The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Posted
Count of Participants
Participants
Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Primary
Stage 2: Percentage of Participants Who Met Criteria for PCS Vital Sign Values (Blood Pressure, Pulse Rate, Weight, Respiration Rate, and Temperature)
The percentage of participants who met PCS criteria at least once postbaseline for vital sign values at Day 42 (Visit 6) (sitting systolic and diastolic blood pressure, pulse rate, weight, respiration rate, and temperature). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Safety Population. The Overall Number Analyzed for each arm refers to the overall number of participants with data available for the given assessment.
Posted
Count of Participants
Participants
Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Primary
Stage 2: Percentage of Participants Who Met Criteria for PCS Electrocardiogram (ECG) Values
The percentage of participants who have PCS ECG at Visit 6 (but not baseline) pre and post-controlled adverse environment (CAE). The numerator for the incidence is the number of participants with non-PCS baseline and at least one post-baseline value meeting the specific criterion at the visit. The denominator is the number of participants with non-PCS baseline and at least one post-baseline assessment at the visit. If a participant did not have a baseline value, but met the criterion post-baseline, then the participant is counted in the numerator.
Safety Population. The Overall Number Analyzed for each arm refers to the overall number of participants with data available for the given assessment.
Posted
Count of Participants
Participants
Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Primary
Stage 2: Mean Change From Baseline in Intraocular Pressure (IOP)
At least 2 IOP measurements were taken by qualified study site personnel using a Goldmann applanation tonometer affixed to a slit lamp with the participant seated. Average intraocular pressure = mean of the 2 (or 3) measures in the study eye and non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Safety Population
Posted
Mean
Standard Deviation
mmHg
Day 1, Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG002
Primary
Stage 2: Mean Change From Baseline in Best-corrected Visual Acuity (BCVA)
BCVA was quantified using the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity protocol in the study eye and the non-study eye. Total fluorescein scores and Schirmer values were used to determine the study eye, and if both eyes qualified, the right eye was designated by default.
Safety Population
Posted
Mean
Standard Deviation
letters
Day 1, Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG002
Stage 2 Cohort 2: AGN-231868 (High Dose)
Primary
Stage 2: Slit-lamp Biomicroscopy: Percentage of Participants With Any Clinically Significant Finding Postbaseline
Percentage of participants with a clinically significant finding postbaseline, post-CAE. A clinically significant finding is defined as more than one severity grade increase (worsening) from baseline or positive status change from absence at baseline to presence at postbaseline (not associated with a severity grade) in one or both eyes.
Safety Population
Posted
Count of Participants
Participants
Day 1 to Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG002
Primary
Stage 2: Percentage of Participants With Any Clinically Significant Postbaseline Findings During Dilated Fundus Examination
The fundus (posterior pole; periphery, when dilated) was evaluated for pathology. Ophthalmoscopy with clinically significant findings (per investigator assessment) postbaseline are reported.
Safety Population
Posted
Count of Participants
Participants
Day 1 to Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG002
Stage 2 Cohort 2: AGN-231868 (High Dose)
Primary
Stage 2: Drop Tolerability Questionnaire Score (Post-controlled Adverse Environment)
Acute overall tolerability attributes of study interventions on an 8-question visual analog scale (VAS) Drop Tolerability Questionnaire. Participants completed questionnaires after exposure to a controlled adverse environment (CAE) for approximately 90 minutes. Visual scale ranges from 0 = not at all comfortable to 100 = very comfortable. Higher mean scores indicate higher levels of comfort with the assigned intervention.
Safety Population
Posted
Mean
Standard Deviation
score on a scale
Day 42 (Post-CAE)
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Secondary
Stage 2: Trough Plasma Concentration (Ctrough) and Plasma Concentration at 0.5 Hours Postdose (C0.5h)
Trough plasma concentration (Ctrough) and plasma concentration at 0.5 hours postdose (C0.5h), following twice daily dosing for up to 6 weeks
PK population (Stage 2). In Stage 2, post-dose trough plasma concentrations of AGN-242428 or AGN-231868 only were assessed as planned using descriptive statistics.
Posted
Mean
Standard Deviation
pg/mL
Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Secondary
Stage 2: Trough Tear Concentration (Ctrough) and Tear Concentration at 0.5 Hours Postdose (C0.5h)
Trough tear concentration (Ctrough) and tear concentration at 0.5 hours postdose (C0.5h), following twice daily dosing for up to 6 weeks
PK population (Stage 2)
Posted
Mean
Standard Deviation
ng/mL
Day 42
ID
Title
Description
OG000
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG001
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Time Frame
All-cause mortality and adverse event tables include events reported from time of informed consent to the end of the study. The median time participants were followed ranged from 20 to 24 days for each cohort in Stage 1. The median time participants were followed ranged from 64 to 65 days for each cohort in Stage 2.
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Stage 1 Cohort 1A: AGN-242428 (Low Dose)
Participants received AGN-242428 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
0
9
0
9
5
9
EG001
Stage 1 Cohort 1A: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
0
3
0
3
1
3
EG002
Stage 1 Cohort 1A: AGN-231868 (Low Dose)
Participants received AGN-231868 (Low dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
0
9
0
9
4
9
EG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
0
3
0
3
2
3
EG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
0
9
0
9
3
9
EG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
0
3
0
3
2
3
EG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5)
0
9
0
9
2
9
EG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
0
3
0
3
0
3
EG008
Stage 2 Cohort 2: AGN-242428 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-242428 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
0
49
0
49
20
49
EG009
Stage 2 Cohort 2: AGN-242428 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
0
49
0
49
22
49
EG010
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42
0
47
1
47
10
47
EG011
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
0
50
0
50
24
50
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
MITRAL VALVE DISEASE MIXED
Cardiac disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG0030 events0 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected49 at risk
EG0090 events0 affected49 at risk
EG0101 events1 affected47 at risk
EG0110 events0 affected49 at risk
EG0120 events0 affected50 at risk
PANCREATITIS
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
LYMPHOMA
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
AORTIC STENOSIS
Vascular disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
CATARACT
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG0031 events1 affected3 at risk
EG0040 events0 affected9 at risk
EG0050 events0 affected3 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected3 at risk
EG0080 events0 affected49 at risk
EG0090 events0 affected49 at risk
EG0100 events0 affected47 at risk
EG0110 events0 affected49 at risk
EG0120 events0 affected50 at risk
CONJUNCTIVAL HYPERAEMIA
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0002 events2 affected9 at risk
EG0011 events1 affected3 at risk
EG0023 events3 affected9 at risk
EG003
EYE IRRITATION
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
EYE PAIN
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
EYE PRURITUS
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
EYELIDS PRURITUS
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
FOREIGN BODY SENSATION IN EYES
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0021 events1 affected9 at risk
EG003
VISION BLURRED
Eye disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
FOOD POISONING
Gastrointestinal disorders
MedDRA 24.1
Systematic Assessment
EG0001 events1 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
COVID-19
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
EAR INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
HERPES ZOSTER
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
URINARY TRACT INFECTION
Infections and infestations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
BLOOD PRESSURE DIASTOLIC INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
BLOOD PRESSURE INCREASED
Investigations
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
DYSGEUSIA
Nervous system disorders
MedDRA 24.1
Systematic Assessment
EG0000 events0 affected9 at risk
EG0010 events0 affected3 at risk
EG0020 events0 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
Title
Denominators
Categories
Plasma Single Dose Administration: Day 2 (Visit 3)
Title
Measurements
OG000NA± NAConcentration at Visit 3 was below limit of quantitation (\< 50 pg/mL)
OG0012740± 2180
OG0021430± 1300
OG00332200± 26100
Plasma Repeat Dose Administration: Day 15 (Visit 5)
Title
Measurements
OG000805± 509
OG0013540± 2250
OG0023790± 4410
OG003
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
eyes
OG00018
OG00118
OG00218
OG00318
Title
Denominators
Categories
Tear Single Dose Administration: Day 2 (Visit 3)
Title
Measurements
OG0003720± 5570
OG0012530± 3060
OG0027420± 6440
OG00350900± 85500
Tear Repeat Dose Administration: Day 15 (Visit 5)
Title
Measurements
OG00014900± 39500
OG0014540± 5730
OG00215100± 19500
OG003
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
Title
Denominators
Categories
Plasma Single Dose Administration: Day 2 (Visit 3)
Title
Measurements
OG000NA± NAConcentration at Visit 3 was below limit of quantitation (BLQ; \< 50 pg/mL)
OG001504± 402
OG002255± 176
OG0035790± 4320
Plasma Repeat Dose Administration: Day 15 (Visit 5)
Title
Measurements
OG000108± 30
OG001513± 277
OG002449± 479
OG003
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
eyes
OG00018
OG00118
OG00218
OG00318
Title
Denominators
Categories
Tear Single Dose Administration: Day 2 (Visit 3)
Title
Measurements
OG0001890± 2780
OG0011630± 1780
OG0023570± 2810
OG00317000± 26300
Tear Repeat Dose Administration: Day 15 (Visit 5)
Title
Measurements
OG0005370± 9550
OG0012250± 2940
OG0026090± 7120
OG003
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
Title
Denominators
Categories
Plasma Single Dose Administration: Day 2 (Visit 3)
Title
Measurements
OG000NA± 0.306Concentration at Visit 3 was below limit of quantitation (\< 50 pg/mL)
OG0011.75± 0.415
OG0021.75± 1.17
OG0031.75± 1.02
Plasma Repeat Dose Administration: Day 15 (Visit 5)
Title
Measurements
OG0001.92± 0.939
OG0010.983± 1.04
OG0021.78± 1.4
OG003
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
eyes
OG00018
OG00118
OG00218
OG00318
Title
Denominators
Categories
Tear Single Dose Administration: Day 2 (Visit 3)
Title
Measurements
OG0000.592± 0.869
OG0010.600± 2.28
OG0020.575± 0.46
OG0030.933± 1.95
Tear Repeat Dose Administration: Day 15 (Visit 5)
Title
Measurements
OG0000.575± 0.077
OG0010.550± 0.444
OG0020.700± 0.824
OG003
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0017
OG0023
OG0037
Title
Denominators
Categories
Title
Measurements
OG000NA± NAConcentration at Visit 3 was below limit of quantitation (\< 50 pg/mL)
OG0014.98± 0.939
OG0026.09± 2.00
OG0033.60± 0.893
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0003
OG0018
OG0024
OG0038
Title
Denominators
Categories
Title
Measurements
OG00016.2± 4.32
OG0015.94± 1.72
OG00211.5± 2.11
OG0036.51± 4.43
OG002
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
eyes
OG00018
OG00118
OG00218
OG00318
Title
Denominators
Categories
Tear Single Dose Administration: Day 2 (Visit 3)
ParticipantsOG0003
ParticipantsOG0017
ParticipantsOG0029
ParticipantsOG0033
eyesOG0006
eyesOG00114
eyesOG00218
eyesOG0036
Title
Measurements
OG0006.65± 6.28
OG0014.76± 4.02
OG0022.47± 0.883
OG003
Tear Repeat Dose Administration: Day 15 (Visit 5)
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG0029
ParticipantsOG0036
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
eyes
OG00018
OG00118
OG00218
OG00318
Title
Denominators
Categories
Title
Measurements
OG0001050± 3760
OG001171± 331
OG002677± 1710
OG003897± 1670
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
Title
Denominators
Categories
Title
Measurements
OG00073.7± 14.9
OG001183± 115
OG002237± 281
OG0031650± 1320
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG003
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0019
OG0029
OG0039
Title
Denominators
Categories
Plasma
Title
Measurements
OG000NA± NAAll concentrations at Visit 3 were BLQ
OG0011.50± 0.68
OG0022.94± 1.83
OG0031.90± 1.82
Tear
Title
Measurements
OG0003.53± 3.97
OG0015.04± 8.36
OG0022.13± 2.15
OG003
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
How comfortable are the study eye drops in your eyes?
Title
Measurements
OG00072.4± 14.65
OG00168.0± 41.87
OG00289.8± 9.93
OG00384.0± 17.09
OG00457.6± 23.50
OG00572.3± 23.46
OG00677.2± 21.29
OG00762.0± 11.14
How soothing are the study eye drops in your eyes?
Title
Measurements
OG00071.8± 11.76
OG00171.7± 42.16
OG00288.6± 10.00
OG003
How moistening/lubricating are the study eye drops in your eyes?
Title
Measurements
OG00071.6± 9.62
OG00189.3± 11.59
OG00286.3± 14.04
OG003
How clear is your vision with the study eye drops in your eyes?
Title
Measurements
OG00067.4± 11.19
OG00167.7± 45.65
OG00273.1± 29.16
OG003
How much stickiness do you have with the study eye drops in your eyes?
Title
Measurements
OG00068.0± 16.73
OG00169.0± 46.77
OG00276.9± 29.68
OG003
How much blur do you have with the study eye drops in your eyes?
Title
Measurements
OG00060.8± 21.31
OG00168.7± 46.48
OG00274.1± 30.06
OG003
How much burning/stinging do you have with the study eye drops in your eyes?
Title
Measurements
OG00068.6± 22.04
OG00176.0± 33.81
OG00281.3± 27.73
OG003
How much discomfort do you have with the study eye drops in your eyes?
Title
Measurements
OG00077.8± 7.69
OG00170.0± 38.43
OG00279.1± 28.16
OG003
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
Eosinophils (10^9/L) (> 1.5 * upper limit of normal [ULN])
ParticipantsOG0009
ParticipantsOG0013
ParticipantsOG0029
ParticipantsOG0033
ParticipantsOG0049
ParticipantsOG0053
ParticipantsOG0069
ParticipantsOG0073
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematocrit (Ratio) (< 0.8 * lower limit of normal (LLN) or >= 1.2 * ULN)
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
Systolic Blood Pressure (mmHg) (<=90 and Decrease of >=20 or >=180 and Increase of >=20)
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Diastolic Blood Pressure (mmHg) (<=50 and Decrease of >=15 or >=105 and Increase of >=15)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Pulse Rate (beats/min) (<=50 and Decrease of >=15 or >=120 and Increase of >=15
Title
Measurements
OG0000
OG0010
OG0020
OG003
Weight (kg) Decrease of >=7% or Increase of >=7%
Title
Measurements
OG0001
OG0010
OG0020
OG003
Respiratory Rate (breaths/min) (<=8 or >=28)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Temperature (C) (<35 or >38)
Title
Measurements
OG0000
OG0010
OG0020
OG003
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
QRS Interval (msec) actual value of >=150
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
PR Interval (msec) actual value of >=250
Title
Measurements
OG0000
OG0010
OG0020
OG003
QTc Fridericia (msec) actual value of > 500 or Increase of > 60
Title
Measurements
OG0000
OG0010
OG0021
OG003
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
Day 2: Right eye
Title
Measurements
OG000-1.06± 1.782
OG0010.67± 1.528
OG002-0.44± 3.005
OG0030.33± 1.528
OG0040.11± 2.837
OG005-0.17± 1.443
OG006-0.17± 2.385
OG007-1.83± 2.021
Day 2: Left eye
Title
Measurements
OG000-1.75± 2.053
OG0011.00± 2.000
OG0020.22± 3.270
OG003
Day 8: Right eye
Title
Measurements
OG0000.17± 2.291
OG001-1.33± 1.155
OG0020.11± 2.804
OG003
Day 8: Left eye
Title
Measurements
OG0000.00± 2.062
OG001-0.67± 1.528
OG0020.56± 2.920
OG003
Day 15: Right eye
Title
Measurements
OG000-1.17± 1.620
OG001-2.67± 3.055
OG002-1.11± 1.691
OG003
Day 15: Left eye
Title
Measurements
OG000-1.44± 1.810
OG001-0.67± 2.082
OG002-0.44± 1.590
OG003
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
Day 2: Right eye
Title
Measurements
OG000-0.9± 2.10
OG0010.3± 1.53
OG002-0.1± 1.96
OG003-1.7± 2.31
OG004-0.6± 2.83
OG0053.3± 3.21
OG0060.0± 2.29
OG007-3.7± 3.06
Day 2: Left eye
Title
Measurements
OG0000.8± 4.71
OG0011.0± 4.58
OG0020.1± 3.22
OG003
Day 8: Right eye
Title
Measurements
OG000-2.1± 3.55
OG0010.3± 1.15
OG002-0.4± 1.74
OG003
Day 8: Left eye
Title
Measurements
OG0001.2± 4.18
OG0012.7± 5.69
OG002-0.7± 2.40
OG003
Day 15: Right eye
Title
Measurements
OG000-0.9± 2.47
OG0010.3± 0.58
OG002-2.3± 3.39
OG003
Day 15: Left eye
Title
Measurements
OG0000.3± 0.87
OG0011.0± 3.61
OG002-1.0± 3.00
OG003
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
Right eye
Title
Measurements
OG0007
OG0011
OG0024
OG0032
OG0041
OG0052
OG0066
OG0073
Left eye
Title
Measurements
OG0005
OG0011
OG0023
OG003
OG003
Stage 1 Cohort 1A: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG004
Stage 1 Cohort 1B: AGN-242428 (High Dose)
Participants received AGN-242428 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG005
Stage 1 Cohort 1B: AGN-242428 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG006
Stage 1 Cohort 1B: AGN-231868 (High Dose)
Participants received AGN-231868 (High dose) in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
OG007
Stage 1 Cohort 1B: AGN-231868 Vehicle
Participants received Vehicle in the left eye on Day 1 (Visit 2). Starting on Day 2, participants administered the same randomized study drug twice daily to both eyes through Day 14, followed by a single-dose administration to both eyes on Day 15 (Visit 5).
Units
Counts
Participants
OG0009
OG0013
OG0029
OG0033
OG0049
OG0053
OG0069
OG0073
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
OG0040
OG0050
OG0060
OG0070
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-31868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00349
OG00450
Title
Denominators
Categories
Title
Measurements
OG00021
OG00122
OG00218
OG00310
OG00425
OG002
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-31868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00349
OG00450
Title
Denominators
Categories
Eosinophils (10^9/L) (> 1.5 * upper limit of normal [ULN])
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00244
ParticipantsOG00344
ParticipantsOG00446
Title
Measurements
OG0000
OG0010
OG0020
OG003
Hematocrit (%) (Low: < 0.8 x LLN or High: >= 1.2 x ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00243
ParticipantsOG003
Hemoglobin (g/L) (< 0.8 * LLN or >= 1.2 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00244
ParticipantsOG00344
Lymphocytes (10^9/L) (< 0.8 * LLN or > 1.2 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00245
ParticipantsOG003
Neutrophils (10^9/L) (< 0.6 * LLN or > 1.6 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00245
ParticipantsOG003
Platelets (10^9/L) (< 0.5 * LLN or > 1.5 * ULN)
ParticipantsOG00042
ParticipantsOG00149
ParticipantsOG00245
ParticipantsOG003
Red blood cells (10^12/L) (< 0.8 * LLN or > 1.2 * ULN)
ParticipantsOG00043
ParticipantsOG00149
ParticipantsOG00242
ParticipantsOG003
White blood cells (10^9/L) (< 0.7 * LLN or > 1.8 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00243
ParticipantsOG003
Alanine Aminotransferase (U/L) (> 3.0 * ULN)
ParticipantsOG00043
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG00344
Albumin (g/L) (< 0.9 * LLN or > 1.1 * ULN
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG00344
Alkaline Phosphatase (U/L) (> 3.0 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG00344
Aspartate Aminotransferase (U/L) (> 3.0 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG003
Bilirubin (umol/L) (> 1.5 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00245
ParticipantsOG00344
Blood Urea Nitrogen (mmol/L) (> 1.3 * ULN)
ParticipantsOG00044
ParticipantsOG00147
ParticipantsOG00241
ParticipantsOG00342
Calcium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG00344
Cholesterol (mmol/L) (> 1.2 * ULN)
ParticipantsOG00035
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG00341
Creatinine (umol/L) (> 1.8 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00245
ParticipantsOG00344
Glucose (mmol/L) (< 0.8 * LLN or > 1.4 * ULN)
ParticipantsOG00041
ParticipantsOG00145
ParticipantsOG00244
ParticipantsOG00341
Potassium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG003
Protein (g/L) (< 0.9 * LLN or > 1.1 * ULN)
ParticipantsOG00043
ParticipantsOG00148
ParticipantsOG00245
ParticipantsOG00344
Sodium (mmol/L) (< 0.9 * LLN or > 1.1 * ULN)
ParticipantsOG00044
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG00344
Glucose (Urinalysis) (>= 2+)
ParticipantsOG00040
ParticipantsOG00143
ParticipantsOG00244
ParticipantsOG00338
pH (Urinalysis) (< 0.9 * LLN or > 1.1 * ULN)
ParticipantsOG00045
ParticipantsOG00148
ParticipantsOG00246
ParticipantsOG00344
Protein (Urinalysis) (>= 2+)
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00244
ParticipantsOG00343
Specific Gravity (Urinalysis) (> 1.1 * ULN)
ParticipantsOG00045
ParticipantsOG00149
ParticipantsOG00246
ParticipantsOG00344
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG002
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-31868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00045
OG00149
OG00246
OG00344
OG00448
Title
Denominators
Categories
Systolic: High (Actual Value >= 180 mmHg and Change from baseline Increase of >= 20 mmHg)
Title
Measurements
OG0000
OG0011
OG0020
OG0030
OG0040
Systolic: Low (Actual Value <= 90 mmHg and Change from baseline decrease of >= 20 mmHg)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Diastolic: High (Actual Value >= 105 mmHg and Change from baseline increase of >= 15 mmHg)
Title
Measurements
OG0000
OG0011
OG0020
OG003
Diastolic: Low (Actual Value <= 50 mmHg and Change from baseline Increase of >= 15 mmHg)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting Pulse Rate (BPM) High (Actual Value >=120 and Change from baseline increase >=15)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Sitting Pulse Rate (BPM) Low (Actual Value <= 50 and Change from baseline decrease of >= 15)
Title
Measurements
OG0000
OG0010
OG0020
OG003
Weight (kg) (High [Change from baseline Increase >=7%] or Low (Change from baseline Decrease >=7%)]
Title
Measurements
OG0001
OG0011
OG0020
OG003
Respiratory rate (BPM) (High [Actual Value >= 28] or Low [Actual Value <= 8])
Title
Measurements
OG0001
OG0011
OG0020
OG003
Temperature (C) (High [Actual Value >38] or Low [Actual Value <35])
Title
Measurements
OG0001
OG0012
OG0022
OG003
OG002
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00019
OG00122
OG00221
OG00319
OG00421
Title
Denominators
Categories
Pre-CAE: QRS Interval (msec) actual value of >=150
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG00318
ParticipantsOG00421
Title
Measurements
OG0001
OG0010
OG0020
OG003
Post-CAE: QRS Interval (msec) actual value of >=150
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG003
Pre-CAE: PR Interval (msec) actual value of >=250
ParticipantsOG00017
ParticipantsOG00122
ParticipantsOG00219
ParticipantsOG003
Post-CAE: PR Interval (msec) actual value of >=250
ParticipantsOG00017
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG003
Pre-CAE: QTc Fridericia (msec) actual value of > 500
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG003
Post-CAE: QTc Fridericia (msec) actual value of > 500
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG003
Pre-CAE: QTc Fridericia (msec) Increase of > 60
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG003
Post-CAE: QTc Fridericia (msec) Increase of > 60
ParticipantsOG00019
ParticipantsOG00122
ParticipantsOG00221
ParticipantsOG003
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00349
OG00450
Title
Denominators
Categories
Study eye
Title
Measurements
OG0000.7± 2.37
OG0010.2± 2.65
OG002-0.5± 2.57
OG0030.2± 2.05
OG004-0.1± 2.37
Non-study eye
Title
Measurements
OG0000.9± 2.23
OG0010.3± 2.58
OG002-0.6± 2.56
OG003
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00349
OG00450
Title
Denominators
Categories
Study eye
Title
Measurements
OG0000.7± 3.96
OG0011.2± 4.16
OG0020.5± 4.13
OG0030.9± 2.80
OG0041.4± 4.11
Non-study eye
Title
Measurements
OG000-0.0± 4.02
OG0010.3± 3.35
OG0020.3± 6.26
OG003
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00349
OG00450
Title
Denominators
Categories
Title
Measurements
OG0009
OG00116
OG00210
OG0038
OG00414
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00349
OG00450
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG0040
OG002
Stage 2 Cohort 2: AGN-231868 (High Dose)
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received AGN-231868 (High dose). Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
OG003
Stage 2 Cohort 2: AGN-231868 Vehicle
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Vehicle. Participants administered assigned study drug in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Participants administered an artificial tear product (REFRESH PLUS®) twice daily to both eyes for 2 weeks (run-in period). After the run-in period, participants received Xiidra (lifitegrast ophthalmic solution). Participants administered Xiidra (lifitegrast ophthalmic solution) in each eye twice daily for 41 days, followed by a single administration during the morning on Day 42.
Units
Counts
Participants
OG00049
OG00149
OG00247
OG00349
OG00450
Title
Denominators
Categories
How comfortable are the study eye drops in your eyes?
Title
Measurements
OG00050.9± 32.71
OG00164.2± 27.75
OG00269.3± 24.12
OG00382.9± 16.68
OG00458.5± 28.18
How soothing are the study eye drops in your eyes?
Title
Measurements
OG00049.5± 30.94
OG00162.2± 27.28
OG00267.4± 24.99
OG003
How moistening/lubricating are the study eye drops in your eyes?
Title
Measurements
OG00058.2± 28.5
OG00167.3± 21.25
OG00270.2± 20.21
OG003
How clear is your vision with the study eye drops in your eyes?
Title
Measurements
OG00060.0± 30.25
OG00168.7± 22.57
OG00266.0± 23.24
OG003
How much stickiness do you have with the study eye drops in your eyes?
Title
Measurements
OG00075.8± 24.52
OG00168.2± 27.37
OG00262.5± 30.42
OG003
How much blur do you have with the study eye drops in your eyes?
Title
Measurements
OG00060.7± 32.55
OG00158.4± 29.91
OG00258.5± 28.68
OG003
How much burning/stinging do you have with the study eye drops in your eyes?
Title
Measurements
OG00047.9± 36.42
OG00152.1± 34.02
OG00254.5± 32.20
OG003
How much discomfort do you have with the study eye drops in your eyes?