A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmi... | NCT03216902 | Trialant
NCT03216902
Sponsor
Santen Inc.
Status
Completed
Last Update Posted
Oct 23, 2020Actual
Enrollment
241Actual
Phase
Phase 2
Conditions
Open-angle Glaucoma, Ocular Hypertension
Interventions
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
Topical ultra-low dose of DE-126 Ophthalmic Solution
Topical low dose of DE-126 Ophthalmic Solution
Topical medium dose of DE-126 Ophthalmic Solution
Topical high dose of DE-126 Ophthalmic Solution
0.005% Latanoprost Ophthalmic Solution
Countries
United States
Japan
Protocol Section
Identification Module
NCT ID
NCT03216902
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
012601IN
Secondary IDs
Not provided
Brief Title
A Phase IIb Safety and Efficacy Study of DE-126 Ophthalmic Solution in Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Official Title
A Phase IIb, Randomized, Observer-Masked, Placebo- and Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-126 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension- Angel Study
Acronym
Not provided
Organization
Santen Inc.INDUSTRY
Status Module
Record Verification Date
Sep 2020
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
Jul 25, 2017Actual
Primary Completion Date
Feb 27, 2018Actual
Completion Date
Feb 27, 2018Actual
First Submitted Date
Jul 11, 2017
First Submission Date that Met QC Criteria
Jul 12, 2017
First Posted Date
Jul 13, 2017Actual
Results Waived
Not provided
Results First Submitted Date
Aug 21, 2020
Results First Submitted that Met QC Criteria
Sep 30, 2020
Results First Posted Date
Oct 23, 2020Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Sep 30, 2020
Last Update Posted Date
Oct 23, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Santen Inc.INDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
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
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
Treatment of elevated pressure in the eye (Intraocular pressure, or 'IOP') with eye drop medications has been shown to be effective in delaying or preventing the progression of glaucoma, and it is the only proven method for reducing the risk of glaucomatous visual field loss.
This study is being conducted to determine how well DE-126 ophthalmic solution works (efficacy) in safely lowering IOP when dosed as topical eyedrops. This study will evaluate the safety and efficacy of four (4) concentrations of DE-126, when compared with latanoprost (0.005%) eye drops in patients with primary open-angle glaucoma or ocular hypertension.
The IOP will be measured at 3 different times throughout the day, over 6 total visits during a 3-month treatment period (with up to 4 extra weeks observation if the patient must stop taking current eye drops to lower IOP). Safety assessments will be done throughout the study, including ocular signs and symptoms, vital signs, and clinical laboratory tests. While the most important time-point to measure IOP in this study and evaluate efficacy will be at the final study visit (month 3), IOP values will also be evaluated at other visits throughout the 3-month treatment period.
Detailed Description
Not provided
Conditions Module
Conditions
Open-angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma
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 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
241Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Placebo (Vehicle of DE-126) followed by high dose of DE-126
Placebo Comparator
Drug: Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
Ultra-low dose 0.0005% DE-126
Experimental
Drug: Topical ultra-low dose of DE-126 Ophthalmic Solution
Low dose 0.001% DE-126
Experimental
Drug: Topical low dose of DE-126 Ophthalmic Solution
Medium dose 0.002% DE-126
Experimental
Drug: Topical medium dose of DE-126 Ophthalmic Solution
High dose 0.003% DE-126
Experimental
Drug: Topical high dose of DE-126 Ophthalmic Solution
0.005% Latanoprost
Active Comparator
Drug: 0.005% Latanoprost Ophthalmic Solution
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution
Drug
Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Intraocular Pressure in the Study Eye at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
9:00, 13:00 and 17:00 at Month 3
Secondary Outcomes
Measure
Description
Time Frame
Intraocular Pressure in the Study Eye at Week 6
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
9:00, 13:00 and 17:00 at Week 6
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Provide signed written informed consent
Diagnosis of POAG or OHT in both eyes
Qualifying corrected visual acuity in each eye
Qualifying central corneal thickness in each eye
Qualifying Day 1 IOP measurement at 3 time-points in both eyes
Qualifying Anterior chamber angle
Exclusion Criteria:
History of ocular surgery specifically intended to lower IOP
Subjects who cannot safely discontinue use of ocular hypotensive medications during the wait/washout period
Advanced glaucoma in either eye
Any corneal abnormality or other condition interfering with or preventing reliable Goldmann applanation tonometry
Any ocular surgery or ocular laser treatment within 90 days prior to Visit 1 (Screening) and throughout the study in either eye
Females who are pregnant, nursing, or planning a pregnancy
Wirta DL, Kuwayama Y, Lu F, Shao H, Odani-Kawabata N. Phase 2b, Randomized, 3-Month, Dose-Finding Study of Sepetaprost in Patients with Primary Open-Angle Glaucoma or Ocular Hypertension: The ANGEL Study. J Ocul Pharmacol Ther. 2022 Apr;38(3):240-251. doi: 10.1089/jop.2021.0077. Epub 2022 Feb 15.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
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
Jun 16, 2017
Jul 28, 2020
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
Single
Masking Description
Not provided
Who Masked
Outcomes Assessor
Placebo (Vehicle of DE-126) followed by high dose of DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution
Drug
Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Ultra-low dose 0.0005% DE-126
Topical low dose of DE-126 Ophthalmic Solution
Drug
Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Low dose 0.001% DE-126
Topical medium dose of DE-126 Ophthalmic Solution
Drug
Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Medium dose 0.002% DE-126
Topical high dose of DE-126 Ophthalmic Solution
Drug
Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
High dose 0.003% DE-126
0.005% Latanoprost Ophthalmic Solution
Drug
0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
0.005% Latanoprost
Xalatan®
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
9:00, 13:00 and 17:00 at Week 1 and Week 2
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
Week 1, Week 2, Week 6 and Month 3.
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%.
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%.
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.
WeeK 1, Week 2, Week 6 and Month 3.
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.
Week 1, Week 2, Week 6 and Month 3.
Mission Hills
California
91345
United States
Eye Research Foundation, INC
Newport Beach
California
92657
United States
North Bay Eye Associates, Inc.
Petaluma
California
94954
United States
Shettle Eye Research, Inc.
Largo
Florida
33773
United States
Clayton Eye Clinical Research, LLC
Morrow
Georgia
30260
United States
Coastal Research Associates, LLC
Roswell
Georgia
30076
United States
Rochester Ophthalmological Group, PC
Rochester
New York
14618
United States
Mundorf Eye Center
Charlotte
North Carolina
28204
United States
Cornerstone Health Care, LLC
High Point
North Carolina
27262
United States
Keystone Research Ltd SMO/Texan Eye, PA
Austin
Texas
78731
United States
Keystone Research LTD SMO/Medical Center Ophthalmology Assoc.
San Antonio
Texas
78240
United States
Murakami Karindoh Hospital
Fukuoka-shi, Fukuoka
Japan
Nagasaka Eye Clinic
Nagoya-shi, Aichi
Japan
Sugiura Eye Clinic
Osaka-shi, Osaka
Japan
Sapporo Katoh Ophthalmology Clinic
Sapporo-shi, Hokkaido
Japan
Dogenzaka Kato Eye Clinic
Shibuya-ku, Tokyo
Japan
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
FG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
FG003
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
FG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
FG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
FG00022 subjects
FG00144 subjects
FG00243 subjects
FG00343 subjects
FG00444 subjects
FG00545 subjects
COMPLETED
FG00020 subjects
FG00143 subjects
FG00242 subjects
FG00343 subjects
FG00443 subjects
FG00542 subjects
NOT COMPLETED
FG0002 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
BG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
BG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
BG003
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
BG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
BG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00022
BG00144
BG00243
BG00343
BG00444
BG00545
BG006241
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
BG00063.2± 11.24
BG00164.4± 9.8
BG00265.5± 13.30
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00013
BG00124
BG002
Race/Ethnicity, Customized
Count of Participants
Participants
Title
Denominators
Categories
Hispanic or Latino
Title
Measurements
BG0002
BG0015
BG002
Region of Enrollment
Number
participants
Title
Denominators
Categories
Japan
Title
Measurements
BG00011
BG00121
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
Intraocular Pressure in the Study Eye at Month 3
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
The number of participants is reduced due to missing data.
Posted
Mean
Standard Deviation
mmHg
9:00, 13:00 and 17:00 at Month 3
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG003
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00243
OG003
Title
Denominators
Categories
9:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG003
Secondary
Intraocular Pressure in the Study Eye at Week 6
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
The number of participants is reduced due to missing data. This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.
Posted
Least Squares Mean
Standard Error
mmHg
9:00, 13:00 and 17:00 at Week 6
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG002
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Secondary
Intraocular Pressure in the Study Eye at Week 1 and Week 2
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
The number of participants is reduced due to missing data.
Posted
Mean
Standard Deviation
mmHg
9:00, 13:00 and 17:00 at Week 1 and Week 2
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG003
Low Dose 0.001% DE-126
Secondary
Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
The number of participants is reduced due to missing data.
Posted
Mean
Standard Deviation
mmHg
Week 1, Week 2, Week 6 and Month 3.
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG003
Low Dose 0.001% DE-126
Secondary
Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
The number of participants is reduced due to missing data.
Posted
Mean
Standard Deviation
mmHg
Week 1, Week 2, Week 6 and Month 3.
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG003
0.001% Low Dose DE-126
Secondary
Percent Change From Baseline (CFB) in Mean Diurnal Intraocular Pressure in the Study Eye at Each Post-baseline Visit
Mean Diurnal IOP was defined as the mean of the IOP values at the three schedules timepoints (9:00, 13:00 and 17:00) at that visit for that subject.
The number of participants is reduced due to missing data.
Posted
Mean
Standard Deviation
Percentage of change
Week 1, Week 2, Week 6 and Month 3.
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG003
Low Dose 0.001% DE-126
Secondary
Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
The number of participants is reduced due to missing data.
Posted
Mean
Standard Deviation
mmHg
9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG003
Secondary
Percent Change From Baseline (CFB) in Intraocular Pressure in the Study Eye at Three Time Points at Each Post-baseline Visit
Intraocular Pressure (IOP),the fluid pressure inside the eye was measured by the Goldmann applanation tonometer in millimeters mercury (mmHg) at 3 time-points throughout the day.
The number of participants is reduced due to missing data.
Posted
Mean
Standard Deviation
Percentage of change in IOP
9:00, 13:00 and 17:00 at Week 1, Week 2, Week 6 and Month 3.
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Secondary
Percentage of Subjects With Mean Diurnal Intraocular Pressure Reduction From Baseline ≥ 20%, 25% and 30% in the Study Eye at Each Post-baseline Visit
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 20%.
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 25%.
A Subject was a responder if the percent reduction from baseline in mean diurnal IOP in the study eye was ≥ 30%.
The number of participants is reduced due to missing data.
Posted
Count of Participants
Participants
WeeK 1, Week 2, Week 6 and Month 3.
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Secondary
Percentage of Subjects With Mean Diurnal Intraocular Pressure ≤ 18 mmHg in the Study Eye at Each Post-baseline Visit
A subject was a responder if the mean diurnal IOP in the study eye was ≤ 18 mmHg.
The number of participants is reduced due to missing data.
Posted
Count of Participants
Participants
Week 1, Week 2, Week 6 and Month 3.
ID
Title
Description
OG000
Placebo (Vehicle of DE-126) Followed by High Dose of DE-126
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
OG001
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
OG002
Ultra-low Dose 0.0005% DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG003
Low Dose 0.001% DE-126
Time Frame
Reporting time frame is from Inform Consent to end of the study at Month3.
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
Placebo P1
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks.
0
22
1
22
2
22
EG001
Placebo P2
Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution: Vehicle of DE-126 Ophthalmic Solution treatment arm dosed by high dose of DE-126 dosed once daily from w6 to month3.
0
20
0
20
10
20
EG002
0.005% Latanoprost
0.005% Latanoprost Ophthalmic Solution: 0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
0
44
0
44
18
44
EG003
Ultra-low Dose DE-126
Topical ultra-low dose of DE-126 Ophthalmic Solution: Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0
43
0
43
13
43
EG004
Low Dose DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0
43
0
43
12
43
EG005
Medium Dose DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0
44
0
44
10
44
EG006
High Dose of DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
0
45
0
45
12
45
EG007
High Dose of DE-126 Total
Summarizes columns High dose of DE-126 and Placebo P2
0
65
0
65
22
65
EG008
DE-126 Total
Total summarizes columns Ultra Low Dose, Low Dose, Medium Dose, High Dose and Placebo P2.
0
195
0
195
57
195
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Muscular weakness
Musculoskeletal and connective tissue disorders
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected44 at risk
EG0030 events0 affected43 at risk
EG0040 events0 affected43 at risk
EG0050 events0 affected44 at risk
EG0060 events0 affected45 at risk
EG0070 events0 affected65 at risk
EG0080 events0 affected195 at risk
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Cataract
Eye disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected44 at risk
EG0030 events0 affected43 at risk
EG0040 events0 affected43 at risk
EG0050 events0 affected44 at risk
EG0061 events1 affected45 at risk
EG0072 events2 affected65 at risk
EG0082 events2 affected195 at risk
Conjunctival Hyperaemia
Eye disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0012 events2 affected20 at risk
EG00213 events12 affected44 at risk
EG003
Eye Irritation
Eye disorders
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected20 at risk
EG0022 events2 affected44 at risk
EG003
Eye Pruritus
Eye disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected20 at risk
EG0025 events5 affected44 at risk
EG003
Growth Of Eyelashes
Eye disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected44 at risk
EG003
Lacrimation Increased
Eye disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0024 events3 affected44 at risk
EG003
Instillation Site Pain
General disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0010 events0 affected20 at risk
EG0020 events0 affected44 at risk
EG003
Pyrexia
General disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected44 at risk
EG003
Alveolar Osteitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected44 at risk
EG003
Sinusitis
Infections and infestations
Systematic Assessment
EG0000 events0 affected22 at risk
EG0013 events3 affected20 at risk
EG0021 events1 affected44 at risk
EG003
Upper Respiratory Tract Infection
Infections and infestations
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0022 events2 affected44 at risk
EG003
Viral Upper Respiratory Tract Infection
Infections and infestations
Systematic Assessment
EG0001 events1 affected22 at risk
EG0010 events0 affected20 at risk
EG0021 events1 affected44 at risk
EG003
Hepatic Enzyme Increased
Investigations
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected44 at risk
EG003
Hypertonic Bladder
Renal and urinary disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected44 at risk
EG003
Skin Lesion
Skin and subcutaneous tissue disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected44 at risk
EG003
Phlebitis
Vascular disorders
Systematic Assessment
EG0000 events0 affected22 at risk
EG0011 events1 affected20 at risk
EG0020 events0 affected44 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
If Institution/Principal Investigator wishes to publish findings, they must submit draft to Santen at least 30 days prior, deleting Confidential Information if requested. Santen must be allowed up to ninety (90) days to determine if patent application is to be filed. Santen has right to first publication of Multi-Center Research results, but if publication doesn't occur within 12 months after completion, Institution/Principal Investigator may individually publish site's results.
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00143
OG00243
OG00344
OG00445
Title
Denominators
Categories
9:00
ParticipantsOG00020
ParticipantsOG00142
ParticipantsOG00243
ParticipantsOG00344
ParticipantsOG00444
Title
Measurements
OG00023.2± 0.66
OG00119.0± 0.46
OG00218.5± 0.46
OG003
13:00
ParticipantsOG00020
ParticipantsOG00142
ParticipantsOG00243
ParticipantsOG00344
17:00
ParticipantsOG00020
ParticipantsOG00142
ParticipantsOG00243
ParticipantsOG00344
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.
t-test, 2 sided
<0.0001
P value is adjusted for multiple comparisons using Hochberg step-up procedure.
Superiority
Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)
OG000
OG002
This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.
t-test, 2 sided
<0.0001
P value is adjusted for multiple comparisons using Hochberg step-up procedure.
Superiority
Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)
OG000
OG003
This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.
t-test, 2 sided
<0.0001
P value is adjusted for multiple comparisons using Hochberg step-up procedure.
Superiority
Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)
OG000
OG004
This endpoint is to test if one of four concentrations of DE-126 is superior to the placebo in lowering IOP at each specified timepoint (9:00, 13:00 and 17:00) at Week 6 compared to baseline. Therefore, 0.005% Latanoprost group is not included in the analysis.
t-test, 2 sided
<0.0001
P value is adjusted for multiple comparisons using Hochberg step-up procedure.
Superiority
Claim superiority of DE-126 compare to Placebo at 3 timepoints (9:00, 13:00 and 17:00)
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00243
OG00343
OG00444
OG00545
Title
Denominators
Categories
Week1 9:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
ParticipantsOG00444
ParticipantsOG00545
Title
Measurements
OG00022.8± 3.99
OG00117.7± 2.67
OG00219.4± 3.32
OG003
Week1 13:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week1 17:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 2 9:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 2 13:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week2 17:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00243
OG00343
OG00444
OG00545
Title
Denominators
Categories
Week 1
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
ParticipantsOG00443
ParticipantsOG00544
Title
Measurements
OG00022.4± 3.48
OG00117.5± 2.12
OG00218.8± 2.95
OG003
Week 2
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 6
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00243
OG00343
OG00444
OG00545
Title
Denominators
Categories
Week 1
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
ParticipantsOG00443
ParticipantsOG00544
Title
Measurements
OG000-2.1± 2.13
OG001-6.7± 2.98
OG002-5.5± 2.41
OG003
Week 2
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 6
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00243
OG00343
OG00444
OG00545
Title
Denominators
Categories
Week 1
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
ParticipantsOG00443
ParticipantsOG00544
Title
Measurements
OG000-8.6± 8.15
OG001-27.3± 10.60
OG002-22.8± 9.59
OG003
Week 2
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 6
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00243
OG00343
OG00444
OG00545
Title
Denominators
Categories
Week 1 9:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
ParticipantsOG00444
ParticipantsOG00545
Title
Measurements
OG000-2.1± 2.68
OG001-7.3± 3.65
OG002-5.3± 2.65
OG003
Week 1 13:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 1 17:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 2 9:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 2 13:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 2 17:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 6 9:00
ParticipantsOG00020
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 6 13:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Week 6 17:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3 at 9:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3 at 13:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3 at 17:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
OG003
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00243
OG00343
OG00444
OG00545
Title
Denominators
Categories
Week 1 9:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
ParticipantsOG00444
ParticipantsOG00545
Title
Measurements
OG000-8.7± 9.58
OG001-28.5± 12.00
OG002-21.6± 10.44
OG003
Week 1 13:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 1 17:00
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 2 9:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 2 13:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 2 17:00
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00243
ParticipantsOG00343
Week 6 9:00
ParticipantsOG00020
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 6 13:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Week 6 17:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3 at 9:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3 at 13:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3 at 17:00
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
OG003
Low Dose 0.001% DE-126
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
Units
Counts
Participants
OG00022
OG00144
OG00242
OG00343
OG00444
OG00545
Title
Denominators
Categories
Week 1- At Least 20% Reduction
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
ParticipantsOG00444
ParticipantsOG00544
Title
Measurements
OG0002
OG00136
OG00222
OG003
Week 1- At Least 25% Reduction
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 1- At Least 30% Reduction
ParticipantsOG00022
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 2- At Least 20% Reduction
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 2- At Least 25% Reduction
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 2- At Least 30% Reduction
ParticipantsOG00021
ParticipantsOG00144
ParticipantsOG00242
ParticipantsOG00343
Week 6- At Least 20% Reduction
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Week 6- At Least 25% Reduction
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Week 6- At Least 30% Reduction
ParticipantsOG00020
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3- At Least 20% Reduction
ParticipantsOG0000
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3- At Least 25% Reduction
ParticipantsOG0000
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Month 3- At Least 30% Reduction
ParticipantsOG0000
ParticipantsOG00143
ParticipantsOG00242
ParticipantsOG00343
Topical low dose of DE-126 Ophthalmic Solution: Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG004
Medium Dose 0.002% DE-126
Topical medium dose of DE-126 Ophthalmic Solution: Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
OG005
High Dose 0.003% DE-126
Topical high dose of DE-126 Ophthalmic Solution: Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks