Safety and Efficacy of PF-04217329 in Patients With Glauc... | NCT00572455 | Trialant
NCT00572455
Sponsor
Pfizer
Status
Completed
Last Update Posted
Apr 30, 2021Actual
Enrollment
318Actual
Phase
Phase 2
Conditions
Primary Open-Angle Glaucoma
Ocular Hypertension
Interventions
PF-04217329 - Lowest Dose
PF-04217329 - Low Dose
PF-04217329 - Middle Dose
PF-04217329 - High Middle Dose
PF-04217329 - High Dose
PF-4217329 - Highest Dose
PF-04217329 - Vehicle
Latanoprost Vehicle
PF-04217329 - Low Dose
Latanoprost Vehicle
PF-04217329 - Middle Dose
Latanoprost Vehicle
PF-04217329 - High Dose
Latanoprost 0.005%
PF-04217329 - Low Dose
Latanoprost 0.005%
PF-04217329 - Middle Dose
Latanoprost 0.005%
PF-04217329 - High Dose
Latanoprost 0.005%
PF-04217329 - Vehicle
Countries
United States
Protocol Section
Identification Module
NCT ID
NCT00572455
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
A0191001
Secondary IDs
Not provided
Brief Title
Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
Official Title
A 2-STAGE, PHASE 2, DOUBLE-MASKED, RANDOMIZED, VEHICLE CONTROLLED, DOSE RESPONSE TRIAL OF PF-04217329 AND THE MARKETED FORMULATION OF LATANOPROST IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
Acronym
Not provided
Organization
PfizerINDUSTRY
Status Module
Record Verification Date
Apr 2021
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
Dec 11, 2007Actual
Primary Completion Date
Jun 26, 2009Actual
Completion Date
Jun 26, 2009Actual
First Submitted Date
Dec 11, 2007
First Submission Date that Met QC Criteria
Dec 11, 2007
First Posted Date
Dec 13, 2007Estimated
Results Waived
Not provided
Results First Submitted Date
Apr 6, 2021
Results First Submitted that Met QC Criteria
Apr 6, 2021
Results First Posted Date
Apr 30, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Feb 17, 2011
Certification/Extension First Submitted that Passed QC Review
Feb 17, 2011
Certification/Extension First Posted Date
Feb 23, 2011Estimated
Last Update Submitted Date
Apr 6, 2021
Last Update Posted Date
Apr 30, 2021Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
PfizerINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
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
To evaluate the safety and efficacy of PF-04217329.
Detailed Description
Not provided
Conditions Module
Conditions
Primary Open-Angle Glaucoma
Ocular Hypertension
Keywords
Open-Angle Glaucoma
Ocular Hypertension
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
318Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Stage 1: PF-04217329 - Lowest Dose
Experimental
Drug: PF-04217329 - Lowest Dose
Stage 1: PF-04217329 - Low Dose
Experimental
Drug: PF-04217329 - Low Dose
Stage 1: PF-04217329 - Middle Dose
Experimental
Drug: PF-04217329 - Middle Dose
Stage 1: PF-04217329 - High Middle Dose
Experimental
Drug: PF-04217329 - High Middle Dose
Stage 1: PF-04217329 - High Dose
Experimental
Drug: PF-04217329 - High Dose
Stage 1: PF-02417329 - Highest Dose
Experimental
Drug: PF-4217329 - Highest Dose
Stage 1: PF-04217329 - Vehicle
Experimental
Drug: PF-04217329 - Vehicle
Interventions
Name
Type
Description
Arm Group Labels
Other Names
PF-04217329 - Lowest Dose
Drug
1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
Stage 1: PF-04217329 - Lowest Dose
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
Stage I: Baseline, Day 14
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
Stage II: Baseline, Day 28
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Secondary Outcomes
Measure
Description
Time Frame
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes.
Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements.
Exclusion Criteria:
Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.
Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period.
Schachar RA, Raber S, Courtney R, Zhang M. A phase 2, randomized, dose-response trial of taprenepag isopropyl (PF-04217329) versus latanoprost 0.005% in open-angle glaucoma and ocular hypertension. Curr Eye Res. 2011 Sep;36(9):809-17. doi: 10.3109/02713683.2011.593725.
See Also Links
Label
URL
To obtain contact information for a study center near you, click here.
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Percentage of participants who reached an IOP of less than or equal to (<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
Stage I: Day 1 up to Day 14
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Percentage of participants who reached an IOP <= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.
Stage II: Day 1 up to Day 28
Newport Beach
California
92663
United States
North Bay Eye Associates, Inc.
Petaluma
California
94954
United States
Centre For Health Care
Poway
California
92064
United States
Atlantic Institute of Clinical Research
Daytona Beach
Florida
32114
United States
Florida Health Care Plans
Daytona Beach
Florida
32114
United States
Eye Associates of Fort Myers
Fort Myers
Florida
33901
United States
International Eye Associates, PA
Ormond Beach
Florida
32174
United States
Coastal Research Associates,LLC
Atlanta
Georgia
30339
United States
Omni Eye Services of Atlanta
Atlanta
Georgia
30342
United States
Eye Care Centers Management, Inc.
Morrow
Georgia
30260
United States
The Eye Group of Southern Indiana
Evansville
Indiana
47710
United States
Taustine Eye Center
Louisville
Kentucky
40217
United States
Rochester Ophthalmological Group, PC
Rochester
New York
14618
United States
Charlotte Eye Ear Nose and Throat Associates, PA
Charlotte
North Carolina
28210
United States
Cornerstone Eye Care
High Point
North Carolina
27262
United States
Mark J. Weiss, MD. Inc.
Tulsa
Oklahoma
74104
United States
Glaucoma Care Center at Century Eye Care
Bristol
Pennsylvania
19007
United States
Wills Eye Institute
Philadelphia
Pennsylvania
19107
United States
Bluestein Custom Vision
Charleston
South Carolina
29414-5893
United States
Total Eye Care, PA
Memphis
Tennessee
38119
United States
Texan Eye Care, PA
Austin
Texas
78746
United States
Eye Physicians of Austin
Austin
Texas
78756
United States
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
FG002
Taprenepag 0.01% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
FG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
FG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
FG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
FG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
FG007
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
FG008
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
FG009
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
FG010
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
FG011
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
FG012
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
FG013
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
FG0009 subjects
FG0019 subjects
FG0029 subjects
FG00310 subjects
FG0049 subjects
FG0059 subjects
FG00612 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0009 subjects
FG0019 subjects
FG0029 subjects
FG00310 subjects
FG0048 subjects
FG0056 subjects
FG00612 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0041 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0053 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Stage II (28 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00735 subjects
FG00836 subjects
FG00936 subjects
FG01036 subjects
FG01136 subjects
FG01236 subjects
FG01336 subjects
Treated
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
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
Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Taprenepag 0.0025% (Stage I)
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
BG001
Taprenepag 0.005% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
BG002
Taprenepag 0.01% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
BG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
BG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
BG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
BG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
BG007
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
BG008
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
BG009
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
BG010
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
BG011
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
BG012
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
BG013
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
BG014
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0009
BG0019
BG0029
BG00310
BG0049
BG0059
BG00612
BG00735
BG00836
BG00936
BG01036
BG01136
BG01236
BG01335
BG014317
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
BG00059.1± 13.0
BG00159.1± 8.1
BG00264.1± 6.8
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0017
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
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
ITT population included all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used to impute missing values.
Posted
Mean
Standard Deviation
mmHg
Stage I: Baseline, Day 14
ID
Title
Description
OG000
Taprenepag 0.0025% (Stage I)
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
OG001
Taprenepag 0.005% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG002
Taprenepag 0.01% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG003
Title
Denominators
Categories
Baseline
Title
Measurements
OG00025.97± 2.420
OG00126.25± 2.400
OG00225.90± 2.094
OG003
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
OG006
Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.028
Least squares (LS) mean difference
3.02
2-Sided
90
0.78
5.25
Superiority or Other (legacy)
OG001
OG006
Primary
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
Posted
Mean
Standard Deviation
mmHg
Stage II: Baseline, Day 28
ID
Title
Description
OG000
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG001
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Primary
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
ITT population included all randomized participants who received at least 1 dose of study medication.
Posted
Count of Participants
Participants
Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
ID
Title
Description
OG000
Taprenepag 0.0025% (Stage I)
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
OG001
Taprenepag 0.005% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG002
Taprenepag 0.01% (Stage I)
Primary
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
ITT population included all randomized participants who received at least 1 dose of study medication.
Posted
Count of Participants
Participants
Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
ID
Title
Description
OG000
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG001
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
Secondary
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Posted
Mean
Standard Deviation
mmHg
Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
ID
Title
Description
OG000
Taprenepag 0.0025% (Stage I)
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
OG001
Taprenepag 0.005% (Stage I)
Secondary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Posted
Mean
Standard Deviation
mmHg
Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
ID
Title
Description
OG000
Taprenepag 0.0025% (Stage I)
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
Secondary
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Posted
Mean
Standard Deviation
mmHg
Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
ID
Title
Description
OG000
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG001
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Secondary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Posted
Mean
Standard Deviation
mmHg
Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
ID
Title
Description
OG000
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
Secondary
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Percentage of participants who reached an IOP of less than or equal to (<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
Posted
Number
percentage of participants
Stage I: Day 1 up to Day 14
ID
Title
Description
OG000
Taprenepag 0.0025% (Stage I)
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
OG001
Taprenepag 0.005% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG002
Taprenepag 0.01% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
Secondary
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Percentage of participants who reached an IOP <= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
Posted
Number
percentage of participants
Stage II: Day 1 up to Day 28
ID
Title
Description
OG000
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG001
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG002
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Time Frame
Not provided
Description
The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
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
Taprenepag 0.0025% (Stage I)
Participants self-administered 1 drop (27 microliter [mcL]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I.
0
9
3
9
EG001
Taprenepag 0.005% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
0
9
3
9
EG002
Taprenepag 0.01% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
0
9
0
9
EG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
0
10
5
10
EG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
0
9
5
9
EG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
0
9
9
9
EG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
0
12
4
12
EG007
Latanoprost Vehicle and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
0
35
18
35
EG008
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
1
36
20
36
EG009
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
2
36
27
36
EG010
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
0
36
24
36
EG011
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
0
36
27
36
EG012
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
0
36
26
36
EG013
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
0
35
15
35
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected12 at risk
EG0070 affected35 at risk
EG0081 affected36 at risk
EG0090 affected36 at risk
EG0100 affected36 at risk
EG0110 affected36 at risk
EG0120 affected36 at risk
EG0130 affected35 at risk
Tachycardia
Cardiac disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Diverticulum
Gastrointestinal disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ear discomfort
Ear and labyrinth disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG0030 affected10 at risk
EG0040 affected9 at risk
EG0050 affected9 at risk
EG0060 affected12 at risk
EG0070 affected35 at risk
EG0080 affected36 at risk
EG0091 affected36 at risk
EG0100 affected36 at risk
EG0110 affected36 at risk
EG0120 affected36 at risk
EG0130 affected35 at risk
Abnormal sensation in eye, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Abnormal sensation in eye, RIGHT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Asthenopia, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blepharitis, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Cataract nuclear, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Chalazion, LEFT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Chorioretinopathy, RIGHT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctival haemorrhage, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctival haemorrhage, RIGHT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctival hyperaemia, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0001 affected9 at risk
EG0012 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctival hyperaemia, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctival hyperaemia, LEFT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctival hyperaemia, RIGHT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctival hyperaemia, RIGHT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctivitis, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal disorder, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal erosion, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal erosion, LEFT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal erosion, RIGHT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal oedema, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Dry eye, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Erythema of eyelid, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Extraocular muscle disorder, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye discharge, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye inflammation, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye irritation, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye pain, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye pain, LEFT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye pain, RIGHT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eye pruritus, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eyelid oedema, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Eyelids pruritus, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Foreign body sensation in eyes, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Foreign body sensation in eyes, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Foreign body sensation in eyes, RIGHT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypermetropia, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Iritis, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Iritis, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Iritis, LEFT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Iritis, RIGHT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Iritis, RIGHT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Lacrimation increased, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Macular oedema, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Myodesopsia, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Myopia, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Ocular discomfort, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Ocular hyperaemia, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Ocular hyperaemia, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Ocular hyperaemia, RIGHT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Open angle glaucoma, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Photophobia, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Photophobia, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vision blurred, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vision blurred, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Vision blurred, RIGHT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Visual acuity reduced, BOTH EYES
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Visual acuity reduced, LEFT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Visual acuity reduced, LEFT EYE, STUDY EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Visual acuity reduced, RIGHT EYE, FELLOW EYE
Eye disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Abdominal pain upper
Gastrointestinal disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Fatigue
General disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Instillation site irritation, BOTH EYES
General disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Instillation site pain, BOTH EYES
General disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Sensation of foreign body, BOTH EYES
General disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Conjunctivitis viral, RIGHT EYE, FELLOW EYE
Infections and infestations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 12.0
Non-systematic Assessment
EG0002 affected9 at risk
EG0011 affected9 at risk
EG0020 affected9 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Sinusitis bacterial
Infections and infestations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Blood glucose increased
Investigations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal staining, BOTH EYES
Investigations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal staining, LEFT EYE, FELLOW EYE
Investigations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Corneal staining, RIGHT EYE, STUDY EYE
Investigations
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Headache, BOTH EYES
Nervous system disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Migraine, BOTH EYES
Nervous system disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Visual field defect, BOTH EYES
Nervous system disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Haematuria
Renal and urinary disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Breast mass
Reproductive system and breast disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Rhinitis allergic
Respiratory, thoracic and mediastinal disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Swelling face
Skin and subcutaneous tissue disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 12.0
Non-systematic Assessment
EG0000 affected9 at risk
EG0010 affected9 at risk
EG0020 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
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Point of Contact
Title
Organization
Phone
Extension
Email
Pfizer ClinicalTrials.gov Call Center
Pfizer, Inc.
1-800-718-1021
ClinicalTrials.gov_Inquiries@pfizer.com
ID
Term
D005902
Glaucoma, Open-Angle
D009798
Ocular Hypertension
Ancestor Terms
ID
Term
D005901
Glaucoma
D005128
Eye Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C568861
PF 04217329
D000077338
Latanoprost
Ancestor Terms
ID
Term
D011461
Prostaglandins F, Synthetic
D011465
Prostaglandins, Synthetic
D011453
Prostaglandins
D015777
Eicosanoids
D005231
Fatty Acids, Unsaturated
D005227
Fatty Acids
D008055
Lipids
D012898
Autacoids
D018836
Inflammation Mediators
D001685
Biological Factors
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG00735 subjects
FG00836 subjects
FG00936 subjects
FG01036 subjects
FG01136 subjects
FG01236 subjects
FG01335 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG00734 subjects
FG00833 subjects
FG00933 subjects
FG01031 subjects
FG01132 subjects
FG01231 subjects
FG01334 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0083 subjects
FG0093 subjects
FG0105 subjects
FG0114 subjects
FG0125 subjects
FG0132 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0093 subjects
FG0103 subjects
FG0114 subjects
FG0125 subjects
FG0131 subjects
Death
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
FG0080 subjects
FG0090 subjects
FG0102 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Other
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0081 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Randomized, but not treated
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
FG0131 subjects
51.8
± 10.4
BG00464.6± 9.6
BG00560.3± 8.5
BG00662.1± 6.5
BG00762.5± 10.7
BG00863.8± 11.4
BG00966.6± 10.1
BG01066.7± 11.4
BG01164.1± 9.1
BG01263.7± 9.4
BG01368.9± 10.2
BG01464.1± 10.5
6
BG00310
BG0043
BG0056
BG0068
BG00725
BG00822
BG00921
BG01024
BG01125
BG01221
BG01322
BG014204
Male
BG0005
BG0012
BG0023
BG0030
BG0046
BG0053
BG0064
BG00710
BG00814
BG00915
BG01012
BG01111
BG01215
BG01313
BG014113
10
OG0049
OG0059
OG00612
26.44
± 1.560
OG00428.10± 3.102
OG00526.26± 1.831
OG00626.04± 2.182
Change at Day 14
Title
Measurements
OG0003.65± 1.749
OG0015.40± 2.508
OG0027.18± 2.749
OG0036.48± 4.278
OG0046.00± 2.748
OG0056.69± 4.563
OG0060.64± 1.382
Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
4.73
2-Sided
90
2.50
6.96
Superiority or Other (legacy)
OG002
OG006
Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.56
2-Sided
90
4.33
8.79
Superiority or Other (legacy)
OG003
OG006
Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.78
2-Sided
90
3.60
7.95
Superiority or Other (legacy)
OG004
OG006
Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.06
2-Sided
90
2.74
7.37
Superiority or Other (legacy)
OG005
OG006
Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.02
2-Sided
90
3.79
8.25
Superiority or Other (legacy)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG002
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG003
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG004
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG005
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG006
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
Units
Counts
Participants
OG00035
OG00136
OG00236
OG00336
OG00436
OG00536
OG00635
Title
Denominators
Categories
Baseline
Title
Measurements
OG00025.75± 2.266
OG00126.47± 2.563
OG00226.69± 2.509
OG00326.98± 2.813
OG00426.36± 2.524
OG00527.34± 2.876
OG00626.81± 2.783
Change at Day 28
Title
Measurements
OG0007.35± 3.559
OG0017.05± 2.875
OG0027.14± 3.462
OG003
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
OG006
Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.171
LS mean difference
1.06
2-Sided
90
-0.21
2.32
Superiority or Other (legacy)
OG001
OG006
Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.553
LS mean difference
0.45
2-Sided
90
-0.80
1.70
Superiority or Other (legacy)
OG002
OG006
Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.555
LS mean difference
0.45
2-Sided
90
-0.80
1.70
Superiority or Other (legacy)
OG003
OG006
Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.053
LS mean difference
1.48
2-Sided
90
0.22
2.73
Superiority or Other (legacy)
OG004
OG006
Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
2.54
2-Sided
90
1.29
3.80
Superiority or Other (legacy)
OG005
OG006
Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to Latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.018
LS mean difference
1.81
2-Sided
90
0.56
3.07
Superiority or Other (legacy)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG00310
OG0049
OG0059
OG00612
Title
Denominators
Categories
Title
Measurements
OG0001
OG0012
OG0020
OG0035
OG0044
OG0059
OG0063
OG002
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG003
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG004
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG005
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG006
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
Units
Counts
Participants
OG00035
OG00136
OG00236
OG00336
OG00436
OG00536
OG00635
Title
Denominators
Categories
Title
Measurements
OG00017
OG00120
OG00227
OG00324
OG00426
OG00526
OG00614
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG002
Taprenepag 0.01% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG00310
OG0049
OG0059
OG00612
Title
Denominators
Categories
Day 1: 8 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00612
Title
Measurements
OG00022.89± 3.140
OG00122.28± 3.709
OG00220.00± 1.677
OG003
Day 7: 8 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 7: 10 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 7: 1 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 7: 4 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 14: 8 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 14: 10 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 14: 1 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 14: 4 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
OG001
Taprenepag 0.005% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG002
Taprenepag 0.01% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG00310
OG0049
OG0059
OG00612
Title
Denominators
Categories
Day0: Baseline for Day 1, 7, 14 8 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
ParticipantsOG0049
ParticipantsOG0059
ParticipantsOG00612
Title
Measurements
OG00027.78± 1.847
OG00127.72± 1.693
OG00227.72± 2.403
OG003
Day 0: Baseline for Day 7 10 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 0: Baseline for Day 7 1 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 0: Baseline for Day 7 4 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 0:Baseline for Day 14 10 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 0:Baseline for Day 14 1 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Day 0:Baseline for Day 14 4 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 1 8 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 7 8 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 7 10 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 7 1 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 7 4 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 14 8 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 14 10 AM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 14 1 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
Change at Day 14 4 PM
ParticipantsOG0009
ParticipantsOG0019
ParticipantsOG0029
ParticipantsOG00310
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
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.011
LS mean difference
3.62
2-Sided
90
1.34
5.90
Superiority or Other (legacy)
OG001
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.004
LS mean difference
4.19
2-Sided
90
1.91
6.47
Superiority or Other (legacy)
OG002
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.47
2-Sided
90
4.19
8.75
Superiority or Other (legacy)
OG003
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.32
2-Sided
90
3.11
7.54
Superiority or Other (legacy)
OG004
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.00
2-Sided
90
3.66
8.33
Superiority or Other (legacy)
OG005
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.80
2-Sided
90
3.52
8.08
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.120
LS mean difference
2.44
2-Sided
90
-0.14
5.02
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.005
LS mean difference
4.55
2-Sided
90
1.97
7.14
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.17
2-Sided
90
3.58
8.75
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.03
2-Sided
90
3.52
8.54
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
7.31
2-Sided
90
4.66
9.95
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its Vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.50
2-Sided
90
2.91
8.08
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.009
LS mean difference
4.04
2-Sided
90
1.56
6.53
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
7.00
2-Sided
90
4.49
9.50
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
7.61
2-Sided
90
5.11
10.11
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
7.08
2-Sided
90
4.64
9.53
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.01
2-Sided
90
3.40
8.62
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
8.70
2-Sided
90
6.11
11.30
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.066
LS mean difference
2.66
2-Sided
90
0.29
5.02
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.006
LS mean difference
4.13
2-Sided
90
1.76
6.50
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.13
2-Sided
90
3.76
8.49
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.81
2-Sided
90
3.51
8.11
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.010
LS mean difference
4.02
2-Sided
90
1.53
6.50
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.48
2-Sided
90
3.03
7.93
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.006
LS mean difference
4.55
2-Sided
90
1.91
7.19
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
5.30
2-Sided
90
2.66
7.94
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
7.51
2-Sided
90
4.87
10.16
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
9.14
2-Sided
90
6.57
11.71
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
5.69
2-Sided
90
2.94
8.44
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.89
2-Sided
90
4.16
9.62
Superiority or Other (legacy)
OG000
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.269
LS mean difference
1.83
2-Sided
90
-0.91
4.58
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.009
LS mean difference
4.49
2-Sided
90
1.75
7.24
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.83
2-Sided
90
4.08
9.57
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.18
2-Sided
90
3.52
8.84
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
5.52
2-Sided
90
2.71
8.33
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.76
2-Sided
90
4.01
9.50
Superiority or Other (legacy)
OG000
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.024
LS mean difference
3.36
2-Sided
90
0.95
5.76
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.24
2-Sided
90
2.82
7.66
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.64
2-Sided
90
4.23
9.06
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.22
2-Sided
90
2.87
7.58
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.012
LS mean difference
3.88
2-Sided
90
1.39
6.37
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.98
2-Sided
90
4.48
9.48
Superiority or Other (legacy)
OG000
OG001
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.003
LS mean difference
4.41
2-Sided
90
2.11
6.72
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.02
2-Sided
90
2.72
7.33
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
6.58
2-Sided
90
4.27
8.88
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.54
2-Sided
90
3.31
7.78
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.003
LS mean difference
4.44
2-Sided
90
2.06
6.82
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
7.08
2-Sided
90
4.70
9.47
Superiority or Other (legacy)
OG000
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.103
LS mean difference
2.41
2-Sided
90
-0.02
4.84
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
0.013
LS mean difference
3.75
2-Sided
90
1.32
6.18
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.96
2-Sided
90
3.53
8.39
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.87
2-Sided
90
3.50
8.23
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.65
2-Sided
90
3.18
8.11
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
5.97
2-Sided
90
3.46
8.48
Superiority or Other (legacy)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG002
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG003
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG004
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG005
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG006
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
Units
Counts
Participants
OG00035
OG00136
OG00236
OG00336
OG00436
OG00536
OG00635
Title
Denominators
Categories
Day 1: 8 AM
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00236
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00536
ParticipantsOG00633
Title
Measurements
OG00019.12± 3.514
OG00121.91± 3.177
OG00220.61± 2.859
OG003
Day 7: 8 AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00336
Day 7: 10 AM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Day 7: 1 PM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Day 7: 4 PM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Day 14: 8 AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00336
Day 14: 10 AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
Day 14: 1 PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
Day 14: 4 PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00332
Day 28: 8 AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00336
Day 28: 10 AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00334
Day 28: 1 PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00334
Day 28: 4 PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
OG001
Latanoprost Vehicle and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG002
Latanoprost Vehicle and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG003
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG004
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG005
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG006
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
Units
Counts
Participants
OG00035
OG00136
OG00236
OG00336
OG00436
OG00536
OG00635
Title
Denominators
Categories
Day 0: Baseline for Day 1: 8AM
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00236
ParticipantsOG00335
ParticipantsOG00436
ParticipantsOG00536
ParticipantsOG00633
Title
Measurements
OG00027.34± 1.525
OG00128.21± 2.349
OG00228.27± 2.155
OG003
Day 0: Baseline for Day 7,14,28: 8AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00336
Day 0: Baseline for Day 7: 10AM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Day 0: Baseline for Day 7: 1PM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Day 0: Baseline for Day 7: 4PM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Day 0: Baseline for Day 14: 10AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
Day 0: Baseline for Day 14: 1PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
Day 0: Baseline for Day 14: 4PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00332
Day 0: Baseline for Day 28: 10AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00334
Day 0: Baseline for Day 28: 1PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00334
Day 0: Baseline for Day 28: 4PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
Change at Day 1: 8AM
ParticipantsOG00034
ParticipantsOG00135
ParticipantsOG00236
ParticipantsOG00335
Change at Day 7: 8AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00336
Change at Day 7: 10AM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Change at Day 7: 1PM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Change at Day 7: 4PM
ParticipantsOG00034
ParticipantsOG00136
ParticipantsOG00233
ParticipantsOG00330
Change at Day 14: 8AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00336
Change at Day 14: 10AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
Change at Day 14: 1PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
Change at Day 14: 4PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00332
Change at Day 28: 8AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00236
ParticipantsOG00336
Change at Day 28: 10AM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00334
Change at Day 28: 1PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00334
Change at Day 28: 4PM
ParticipantsOG00035
ParticipantsOG00136
ParticipantsOG00235
ParticipantsOG00333
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
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.377
LS mean difference
0.72
2-Sided
90
-0.63
2.08
Superiority or Other (legacy)
OG001
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.039
LS mean difference
-1.68
2-Sided
90
-3.01
-0.35
Superiority or Other (legacy)
OG002
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.668
LS mean difference
-0.34
2-Sided
90
-1.67
0.98
Superiority or Other (legacy)
OG003
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.121
LS mean difference
1.26
2-Sided
90
-0.07
2.59
Superiority or Other (legacy)
OG004
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.039
LS mean difference
1.67
2-Sided
90
0.34
2.99
Superiority or Other (legacy)
OG005
OG006
Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.220
LS mean difference
0.99
2-Sided
90
-0.34
2.31
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.098
LS mean difference
1.30
2-Sided
90
0.01
2.59
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.519
LS mean difference
0.50
2-Sided
90
-0.77
1.77
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.724
LS mean difference
0.27
2-Sided
90
-1.00
1.55
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.059
LS mean difference
1.46
2-Sided
90
0.19
2.74
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
2.71
2-Sided
90
1.43
3.98
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.008
LS mean difference
2.09
2-Sided
90
0.82
3.37
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.068
LS mean difference
1.32
2-Sided
90
0.13
2.51
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.994
LS mean difference
0.01
2-Sided
90
-1.16
1.18
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.494
LS mean difference
0.50
2-Sided
90
-0.70
1.69
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.063
LS mean difference
1.39
2-Sided
90
0.16
2.62
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.004
LS mean difference
2.15
2-Sided
90
0.95
3.34
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.004
LS mean difference
2.17
2-Sided
90
0.97
3.38
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.038
LS mean difference
1.55
2-Sided
90
0.32
2.77
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 1 PM : Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.512
LS mean difference
0.48
2-Sided
90
-0.72
1.68
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.373
LS mean difference
0.66
2-Sided
90
-0.56
1.89
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.088
LS mean difference
1.31
2-Sided
90
0.05
2.56
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.004
LS mean difference
2.21
2-Sided
90
0.98
3.44
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.003
LS mean difference
2.33
2-Sided
90
1.09
3.57
Superiority or Other (legacy)
OG000
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.010
LS Mean Difference
1.87
2-Sided
90
0.69
3.04
Superiority or Other (legacy)
OG001
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.205
LS mean difference
0.89
2-Sided
90
-0.27
2.05
Superiority or Other (legacy)
OG002
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.045
LS mean difference
1.44
2-Sided
90
0.26
2.63
Superiority or Other (legacy)
OG003
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.005
LS mean difference
2.09
2-Sided
90
0.88
3.31
Superiority or Other (legacy)
OG004
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
<0.001
LS mean difference
2.51
2-Sided
90
1.33
3.70
Superiority or Other (legacy)
OG005
OG006
Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
2.29
2-Sided
90
1.10
3.48
Superiority or Other (legacy)
OG000
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.757
LS mean difference
0.27
2-Sided
90
-1.15
1.69
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.878
LS mean difference
-0.13
2-Sided
90
-1.54
1.27
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.780
LS mean difference
-0.24
2-Sided
90
-1.64
1.17
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.670
LS mean difference
0.36
2-Sided
90
-1.04
1.77
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.021
LS mean difference
1.98
2-Sided
90
0.58
3.38
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.126
LS mean difference
1.31
2-Sided
90
-0.10
2.71
Superiority or Other (legacy)
OG000
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.215
LS mean difference
0.97
2-Sided
90
-0.32
2.26
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.635
LS mean difference
-0.37
2-Sided
90
-1.65
0.91
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.934
LS mean difference
-0.06
2-Sided
90
-1.35
1.22
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.478
LS mean difference
0.56
2-Sided
90
-0.74
1.87
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
2.57
2-Sided
90
1.26
3.87
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.013
LS mean difference
1.99
2-Sided
90
0.68
3.30
Superiority or Other (legacy)
OG000
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.736
LS mean difference
0.27
2-Sided
90
-1.04
1.57
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.386
LS mean difference
-0.68
2-Sided
90
-1.96
0.61
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.948
LS mean difference
-0.05
2-Sided
90
-1.35
1.24
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.908
LS mean difference
-0.09
2-Sided
90
-1.41
1.22
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.015
LS mean difference
1.97
2-Sided
90
0.65
3.28
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.046
LS mean difference
1.60
2-Sided
90
0.29
2.92
Superiority or Other (legacy)
OG000
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.042
LS mean difference
1.60
2-Sided
90
0.31
2.89
Superiority or Other (legacy)
OG001
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.940
LS mean difference
0.06
2-Sided
90
-1.22
1.34
Superiority or Other (legacy)
OG002
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.114
LS mean difference
1.24
2-Sided
90
-0.05
2.53
Superiority or Other (legacy)
OG003
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.228
LS mean difference
0.97
2-Sided
90
-0.35
2.28
Superiority or Other (legacy)
OG004
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.005
LS mean difference
2.29
2-Sided
90
0.98
3.60
Superiority or Other (legacy)
OG005
OG006
Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.063
LS mean difference
1.48
2-Sided
90
0.17
2.79
Superiority or Other (legacy)
OG000
OG006
Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.562
LS mean difference
0.50
2-Sided
90
-0.92
1.91
Superiority or Other (legacy)
OG001
OG006
Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.431
LS mean difference
0.67
2-Sided
90
-0.73
2.07
Superiority or Other (legacy)
OG002
OG006
Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.795
LS mean difference
0.22
2-Sided
90
-1.18
1.62
Superiority or Other (legacy)
OG003
OG006
Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.032
LS mean difference
1.83
2-Sided
90
0.43
3.23
Superiority or Other (legacy)
OG004
OG006
Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
2.73
2-Sided
90
1.34
4.13
Superiority or Other (legacy)
OG005
OG006
Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.017
LS mean difference
2.04
2-Sided
90
0.64
3.44
Superiority or Other (legacy)
OG000
OG006
Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.124
LS mean difference
1.26
2-Sided
90
-0.09
2.60
Superiority or Other (legacy)
OG001
OG006
Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.920
LS mean difference
0.08
2-Sided
90
-1.25
1.41
Superiority or Other (legacy)
OG002
OG006
Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.887
LS mean difference
-0.12
2-Sided
90
-1.46
1.22
Superiority or Other (legacy)
OG003
OG006
Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.083
LS mean difference
1.42
2-Sided
90
0.08
2.77
Superiority or Other (legacy)
OG004
OG006
Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
2.65
2-Sided
90
1.29
4.01
Superiority or Other (legacy)
OG005
OG006
Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.006
LS mean difference
2.30
2-Sided
90
0.94
3.66
Superiority or Other (legacy)
OG000
OG006
Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.533
LS mean difference
0.49
2-Sided
90
-0.80
1.78
Superiority or Other (legacy)
OG001
OG006
Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.985
LS mean difference
-0.02
2-Sided
90
-1.29
1.26
Superiority or Other (legacy)
OG002
OG006
Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.665
LS mean difference
0.34
2-Sided
90
-0.95
1.62
Superiority or Other (legacy)
OG003
OG006
Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.276
LS mean difference
0.86
2-Sided
90
-0.44
2.15
Superiority or Other (legacy)
OG004
OG006
Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.004
LS mean difference
2.34
2-Sided
90
1.04
3.65
Superiority or Other (legacy)
OG005
OG006
Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.011
LS mean difference
2.04
2-Sided
90
0.74
3.35
Superiority or Other (legacy)
OG000
OG006
Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.033
LS mean difference
1.78
2-Sided
90
0.41
3.14
Superiority or Other (legacy)
OG001
OG006
Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.302
LS mean difference
0.84
2-Sided
90
-0.50
2.19
Superiority or Other (legacy)
OG002
OG006
Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.255
LS mean difference
0.94
2-Sided
90
-0.42
2.30
Superiority or Other (legacy)
OG003
OG006
Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.198
LS mean difference
1.08
2-Sided
90
-0.30
2.46
Superiority or Other (legacy)
OG004
OG006
Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.002
LS mean difference
2.68
2-Sided
90
1.30
4.06
Superiority or Other (legacy)
OG005
OG006
Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.
ANCOVA
0.046
LS mean difference
1.68
2-Sided
90
0.30
3.06
Superiority or Other (legacy)
OG003
Taprenepag 0.015% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG004
Taprenepag 0.02% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG005
Taprenepag 0.03% (Stage I)
Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I.
OG006
Taprenepag Vehicle (Stage I)
Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I.
Units
Counts
Participants
OG0009
OG0019
OG0029
OG00310
OG0049
OG0059
OG00612
Title
Denominators
Categories
Title
Measurements
OG0000.0
OG00111.1
OG00211.1
OG0030.0
OG00411.1
OG00522.2
OG0060.0
Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG003
Latanoprost 0.005% and Taprenepag 0.005% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG004
Latanoprost 0.005% and Taprenepag 0.01% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG005
Latanoprost 0.005% and Taprenepag 0.015% (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.
OG006
Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II.