A Phase 2 Study Of The 24-Hour Intraocular Pressure Lowering And Systemic Exposure Of PF-04217329

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00934089
• Collaborator: (none)
• Enrollment: 31
• Locations: 8
• Arms: 2
• Duration (Months): 5
• Patients Per Site: 3.9
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

This study will characterize the effect of PF-04217329, alone and in combination with latanoprost, on circadian intraocular pressure and blood pressure in glaucoma patients. Blood samples will be collected to measure the amount of active metabolite of PF-04217329 in the plasma following dosing.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle; Ocular Hypertension	Drug: PF-04217329; Drug: latanoprost vehicle; Drug: PF-04217329; Drug: latanoprost	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Single-masked, Randomized, Crossover Study Of The 24-hour Intraocular Pressure Lowering And Systemic Exposure of Pf-04217329 Alone And In Combination With Latanoprost
• Study Start Date: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-04217329 + placebo Active study drug + latanoprost vehicle	Drug: PF-04217329; Topical ocular solution, once-daily for 14 days; Drug: latanoprost vehicle; Topical ocular solution, once-daily for 14 days
Experimental: PF-04217329 + latanoprost Active study drug + latanoprost	Drug: PF-04217329; Topical ocular solution, once-daily for 14 days; Drug: latanoprost; Topical ocular solution, once-daily for 14 days; Other Names: Xalatan

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) [8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 14.

2. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) [10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury, 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 AM on Day -8 as baseline for 10 AM value on Day 14.

3. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) [12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 PM on Day -8 as baseline for 12 PM value on Day 14.

4. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) [2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 2 PM on Day -8 as baseline for 2 PM value on Day 14.

5. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) [4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 PM on Day -8 as baseline for 4 PM value on Day 14.

6. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) [6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 6 PM on Day -8 as baseline for 6 PM value on Day 14.

7. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) [8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both the eyes, and eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 PM on Day -8 as baseline for 8 PM value on Day 14.

8. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) [10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 PM on Day -8 as baseline for 10 PM value on Day 14.

9. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) [12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours)]

   IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 AM on Day -7 as baseline for 12 AM value on Day 15.

10. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) [4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours)]

    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 AM on Day -7 as baseline for 4 AM value on Day 15.

11. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours) [6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours)]

    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as the IOP at that time point. If 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 6 AM on Day -7 as baseline for 6 AM value on Day 15.

12. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours) [8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours)]

    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -7 as baseline for 8 AM value on Day 15.

13. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours) [8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours)]

    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 16. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 16.

14. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours) [8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours)]

    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 17. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 17.

15. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours) [8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours)]

    IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 21. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 21.

16. Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14 [5 minutes post-dose on Day 14]

17. Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14 [0.25 hours post-dose on Day 14]

18. Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14 [0.5 hours post-dose on Day 14]

19. Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14 [0.75 hours post-dose on Day 14]

20. Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14 [1 hour post-dose on Day 14]

Secondary Outcome Measures

1. Diastolic Ocular Perfusion Pressure (DOPP) [8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM on Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day 15]

   DOPP = diastolic blood pressure minus IOP of the study eye. IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit and Day 15. IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye.

2. Change From Baseline in Diastolic Ocular Perfusion Pressure (DOPP) at Day 14 (8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM) and Day 15 (12 AM, 2 AM, 4 AM, 6 AM and 8 AM) [8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, and 10 PM on Day -8 (Baseline), Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day -7 (Baseline), Day 15]

   DOPP=diastolic blood pressure minus IOP of the study eye. IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. Change at various post-dose time points on Day 14 and Day 15 was calculated from the values at same time points on Day -8 and Day -7 respectively (for example, value at 8 AM on Day -8 was used as baseline value for 8 AM value on Day 14 and value at 8 AM on Day -7 was used as baseline value for 8 AM value on Day 15).

3. Number of Participants With Ocular and Systemic Adverse Events (AEs) [Baseline up to 28 days after last dose of study medication (up to 58 Days)]

   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. Number of participants with ocular (AE related to eye) and systemic (all AEs including eye) AEs were reported.

4. Percentage of Participants With Photophobia and Iritis [Baseline up to 28 days after last dose of study medication (up to 58 Days)]

   Percentage of participants with treatment emergent photophobia (abnormal sensitivity or intolerance of eye towards light) and iritis (inflammation of the iris of eye) were reported. 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.

5. Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 [8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35]

   Corneal thickness was measured using an ultrasonic pachymeter. Corneal thickness in both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.

6. Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 [8 AM on Day 1 (Baseline), Day 13, 35]

   Endothelial cell count was defined as the number of cells per millimeter square (cells/mm^2) of endothelium and was calculated using confocal microscopy for both study eye and fellow eye. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.

Other Outcome Measures

1. Maximum Conjunctival Hyperemia Score [Day -8 (Baseline), Day 1 to 35]

   Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe). Higher score indicated severe condition. Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1). Highest conjunctival hyperemia score observed at Day -8 (baseline) and through Day 1 to 35 were reported. Maximum conjunctival hyperemia score for both study eye and fellow eye was reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.

2. Change From Baseline in Maximum Conjunctival Hyperemia Score Observed [Day -8 (Baseline), Day 1 to 35]

   Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe). Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1). Change between highest conjunctival hyperemia score observed through Day 1 to 35 and highest conjunctival hyperemia score at baseline (Day -8) was reported. Maximum conjunctival hyperemia score for both study eye and fellow eye was reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.

3. Total Corneal Staining Score [8 AM on Day 1 (Baseline)]

   Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Total corneal score from both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.

4. Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 [8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35]

   Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Total corneal score from both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes

• Intraocular Pressure (IOP) of at least 22 mmHg and not more than 30 mmHg in either eye at 8 AM after discontinuing previous glaucoma treatment

• Visual acuity correctable to 20/100 or better in each eye.

Exclusion Criteria:

• Closed/barely open anterior chamber angle or a history of acute angle closure in either eye.

• Diagnosis of a clinically significant or progressive retinal disease (eg, diabetic retinopathy, macular degeneration) in either eye.

• Advanced glaucoma or a history of severe central visual field loss in either eye.

• History of ocular surgery or trauma in either eye within 6 months of the screening visit.

• History of ocular infection, ocular inflammation, or laser surgery in either eye within 3 months of the screening visit.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West Coast Clinical Trials, LLC	Cypress	California	United States	90630
2	Glory Medical Group	Garden Grove	California	United States	92844
3	East-West Eye Institute	Gardena	California	United States	90247
4	Ophthalmology Corporation	Long Beach	California	United States	90806
5	East-West Eye Institute	Los Angeles	California	United States	90013
6	Los Angeles Eye Medical Group	Los Angeles	California	United States	90057
7	Eye Research Foundation	Newport Beach	California	United States	92663
8	Southern California Glaucoma Consultants	Pasadena	California	United States	91105

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT00934089
• Other Study ID Numbers: A0191002
• First Posted: Jul 8, 2009
• Last Update Posted: May 3, 2021
• Last Verified: Apr 1, 2021

• Additional relevant MeSH terms: Ocular Hypertension; Glaucoma, Open-Angle; Latanoprost

Study Results

Participant Flow

Arm/Group Title	Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle	Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost
Arm/Group Description	Participants self-administered 1 drop (27 microliter [mcL]) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then latanoprost 0.005% ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.
Period Title: First Intervention Period (14 Days)
STARTED	15	16
Treated	14	16
COMPLETED	13	16
NOT COMPLETED	2	0
Period Title: First Intervention Period (14 Days)
STARTED	13	16
COMPLETED	13	16
NOT COMPLETED	0	0
Period Title: First Intervention Period (14 Days)
STARTED	13	16
COMPLETED	13	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle	Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost	Total
Arm/Group Description	Participants self-administered 1 drop (27 microliter [mcL]) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in first intervention period and then latanoprost 0.005% ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in second intervention period. A 28-day washout period was maintained between each period.	Total of all reporting groups
Overall Participants	14	16	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.2 (9.0)	65.2 (11.3)	66.6 (10.3)
Sex: Female, Male (Count of Participants)
Female	11 78.6%	11 68.8%	22 73.3%
Male	3 21.4%	5 31.3%	8 26.7%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 14.
Time Frame	8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour)

Outcome Measure Data

Analysis Population Description

Per-protocol (PP) population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8) : 8 AM	22.77 (3.264)	22.41 (2.786)
Change at Day 14: 8 AM	5.00 (2.391)	3.79 (2.942)

2. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury, 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 AM on Day -8 as baseline for 10 AM value on Day 14.
Time Frame	10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8): 10 AM	21.40 (3.022)	20.82 (2.385)
Change at Day 14: 10 AM	3.90 (2.445)	3.09 (2.822)

3. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 PM on Day -8 as baseline for 12 PM value on Day 14.
Time Frame	12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8): 12 PM	21.54 (3.514)	21.45 (2.518)
Change at Day 14: 12 PM	5.15 (2.482)	4.43 (2.530)

4. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 2 PM on Day -8 as baseline for 2 PM value on Day 14.
Time Frame	2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations. Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8): 2 PM	22.25 (2.766)	20.80 (2.601)
Change at Day 14: 2 PM	6.56 (2.438)	3.91 (2.500)

5. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 PM on Day -8 as baseline for 4 PM value on Day 14.
Time Frame	4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations. Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8): 4 PM	18.56 (3.383)	17.68 (3.403)
Change at Day 14: 4 PM	5.79 (3.333)	4.50 (3.611)

6. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 6 PM on Day -8 as baseline for 6 PM value on Day 14.
Time Frame	6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8): 6 PM	19.10 (3.369)	17.29 (3.326)
Change at Day 14: 6 PM	6.42 (4.655)	3.95 (3.417)

7. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both the eyes, and eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 PM on Day -8 as baseline for 8 PM value on Day 14.
Time Frame	8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8) for Day 14 : 8 PM	18.58 (3.790)	16.66 (3.483)
Change at Day 14: 8 PM	6.44 (4.220)	3.30 (3.425)

8. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 visit was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 10 PM on Day -8 as baseline for 10 PM value on Day 14.
Time Frame	10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -8): 10 PM	18.25 (2.978)	17.96 (3.347)
Change at Day 14: 10 PM	5.40 (3.365)	3.88 (3.693)

9. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 12 AM on Day -7 as baseline for 12 AM value on Day 15.
Time Frame	12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -7): 12 AM	17.98 (3.580)	16.77 (3.770)
Change at Day 15: 12 AM	5.71 (2.400)	4.34 (3.443)

10. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 4 AM on Day -7 as baseline for 4 AM value on Day 15.
Time Frame	4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -7) : 4 AM	16.77 (3.742)	16.66 (2.941)
Change at Day 15: 4 AM	4.31 (3.978)	4.39 (2.551)

11. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as the IOP at that time point. If 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 6 AM on Day -7 as baseline for 6 AM value on Day 15.
Time Frame	6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -7): 6 AM	17.98 (3.952)	17.36 (2.785)
Change at Day 15: 6 AM	5.02 (4.415)	4.32 (2.878)

12. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), mean of 2 readings was recorded as 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -7 as baseline for 8 AM value on Day 15.
Time Frame	8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Baseline (Day -7): 8 AM	23.31 (2.497)	22.71 (2.347)
Change at Day 15: 8 AM	6.19 (2.801)	4.77 (2.518)

13. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 16. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 16.
Time Frame	8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Mean (Standard Deviation) [mmHg]	1.21 (5.009)	-0.20 (3.023)

14. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 17. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 17.
Time Frame	8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations. Here 'overall number of participants analyzed) signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	23	28
Mean (Standard Deviation) [mmHg]	0.89 (3.769)	-0.95 (3.563)

15. Primary Outcome

Title	Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours)
Description	IOP was measured using Perkins applanation tonometer at Day -8 and using standard Goldmann applanation tonometer at eligibility visit and Day 21. IOP was measured in both eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as study eye. IOP was measured twice in the same eye, and if difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of 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 in IOP = baseline IOP - post-baseline IOP. Change was calculated using the value at 8 AM on Day -8 as baseline for 8 AM value on Day 21.
Time Frame	8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours)

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Mean (Standard Deviation) [mmHg]	-0.19 (3.017)	-0.36 (3.197)

16. Primary Outcome

Title	Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14
Time Frame	5 minutes post-dose on Day 14

Outcome Measure Data

Analysis Population Description

Evaluable PK population included all enrolled participants who completed study treatment, had at least 1 quantifiable concentration (that is, at least 1 concentration above the limit of quantification) and had no major protocol deviation. Here 'overall number of participants analyzed' signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	26	27
Mean (Standard Deviation) [pg/mL]	36.20 (23.847)	43.27 (36.290)

17. Primary Outcome

Title	Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14
Time Frame	0.25 hours post-dose on Day 14

Outcome Measure Data

Analysis Population Description

Evaluable PK population included all enrolled participants who completed study treatment, had at least 1 quantifiable concentration (that is, at least 1 concentration above the limit of quantification) and had no major protocol deviation.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	26	28
Mean (Standard Deviation) [pg/mL]	67.23 (33.885)	88.65 (54.679)

18. Primary Outcome

Title	Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14
Time Frame	0.5 hours post-dose on Day 14

Outcome Measure Data

Analysis Population Description

Evaluable PK population included all enrolled participants who completed study treatment, had at least 1 quantifiable concentration (that is, at least 1 concentration above the limit of quantification) and had no major protocol deviation.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	26	28
Mean (Standard Deviation) [pg/mL]	47.88 (29.811)	53.07 (34.336)

19. Primary Outcome

Title	Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14
Time Frame	0.75 hours post-dose on Day 14

Outcome Measure Data

Analysis Population Description

Evaluable PK population included all enrolled participants who completed study treatment, had at least 1 quantifiable concentration (that is, at least 1 concentration above the limit of quantification) and had no major protocol deviation.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	26	28
Mean (Standard Deviation) [pg/mL]	31.68 (20.692)	30.74 (18.726)

20. Primary Outcome

Title	Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14
Time Frame	1 hour post-dose on Day 14

Outcome Measure Data

Analysis Population Description

Evaluable PK population included all enrolled participants who completed study treatment, had at least 1 quantifiable concentration (that is, at least 1 concentration above the limit of quantification) and had no major protocol deviation.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	26	28
Mean (Standard Deviation) [pg/mL]	24.94 (25.301)	18.96 (14.827)

21. Secondary Outcome

Title	Diastolic Ocular Perfusion Pressure (DOPP)
Description	DOPP = diastolic blood pressure minus IOP of the study eye. IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit and Day 15. IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye.
Time Frame	8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM on Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day 15

Outcome Measure Data

Analysis Population Description

The intent-to-treat population included all randomized participants who receive at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively. Last observation carried forward (LOCF) was used to impute missing data.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Day 14: 8AM	57.42 (8.984)	57.48 (12.100)
Day 14: 10AM	48.28 (10.902)	48.29 (10.652)
Day 14: 12PM	52.70 (10.289)	52.84 (10.105)
Day 14: 2PM	49.73 (12.744)	52.52 (10.908)
Day 14: 4PM	56.73 (9.555)	56.75 (9.776)
Day 14: 6PM	59.38 (9.527)	60.41 (9.809)
Day 14: 8PM	58.18 (10.929)	55.98 (10.351)
Day 14: 10PM	51.57 (12.317)	49.86 (10.419)
Day 15: 12AM	51.10 (10.247)	53.52 (12.302)
Day 15: 4AM	54.25 (11.929)	54.00 (11.168)
Day 15: 6AM	54.08 (11.784)	53.90 (11.385)
Day 15: 8AM	57.32 (10.431)	58.47 (10.941)

22. Secondary Outcome

Title	Change From Baseline in Diastolic Ocular Perfusion Pressure (DOPP) at Day 14 (8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, 10 PM) and Day 15 (12 AM, 2 AM, 4 AM, 6 AM and 8 AM)
Description	DOPP=diastolic blood pressure minus IOP of the study eye. IOP was measured using Perkins applanation tonometer at Day -8, Day 14 and using standard Goldmann applanation tonometer at eligibility visit, Day -7 and Day 15. IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. Change at various post-dose time points on Day 14 and Day 15 was calculated from the values at same time points on Day -8 and Day -7 respectively (for example, value at 8 AM on Day -8 was used as baseline value for 8 AM value on Day 14 and value at 8 AM on Day -7 was used as baseline value for 8 AM value on Day 15).
Time Frame	8 AM, 10 AM, 12 PM, 2 PM, 4 PM, 6 PM, 8 PM, and 10 PM on Day -8 (Baseline), Day 14; 12 AM, 4 AM, 6 AM, 8 AM on Day -7 (Baseline), Day 15

Outcome Measure Data

Analysis Population Description

PP population included all participants who completed the study treatment with no major protocol violations. Here 'number analyzed' signifies those participants who were evaluable for this measure at given time points for each group, respectively.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	24	28
Day -8: Baseline for Day 14 8 AM (n=24,28)	52.81 (11.179)	53.05 (13.183)
Day -8: Baseline for Day 14 10 AM(n=24,28)	46.06 (10.862)	44.57 (13.493)
Day -8: Baseline for Day 14 12 PM (n=24,28)	47.29 (10.917)	50.34 (11.341)
Day -8: Baseline for Day 14 2 PM (n=24,28)	46.75 (10.260)	46.13 (9.988)
Day -8: Baseline for Day 14 4 PM (n=24,28)	53.98 (13.218)	52.39 (10.495)
Day -8: Baseline for Day 14 6 PM (n=24,28)	53.98 (12.883)	58.14 (12.280)
Day -8: Baseline for Day 14 8 PM (n=24,28)	52.50 (15.829)	53.77 (13.349)
Day -8: Baseline for Day 14 10 PM (n=24,28)	46.54 (9.894)	47.79 (14.196)
Day -7: Baseline for Day 15 12 AM (n=24,28)	48.73 (9.880)	49.73 (11.843)
Day -7: Baseline for Day 15 4 AM (n=24,28)	51.98 (12.386)	51.73 (10.801)
Day -7: Baseline for Day 15: 6 AM	53.60 (13.672)	54.39 (13.151)
Day -7: Baseline for Day 15: 8 AM	52.94 (10.584)	55.18 (11.923)
Change at Day 14: 8 AM	5.38 (8.403)	4.43 (7.262)
Change at Day 14: 10 AM	2.77 (9.336)	3.70 (11.108)
Change at Day 14: 12 PM	6.65 (8.906)	2.82 (8.790)
Change at Day 14: 2 PM	4.15 (12.645)	7.31 (7.558)
Change at Day 14: 4 PM	3.25 (13.492)	3.98 (7.597)
Change at Day 14: 6 PM	6.00 (10.208)	2.59 (10.723)
Change at Day 14: 8 PM	6.94 (11.900)	2.16 (8.423)
Change at Day 14: 10 PM	5.73 (10.332)	2.05 (10.401)
Change at Day 15: 12 AM	3.04 (6.716)	3.80 (8.231)
Change at Day 15: 4 AM	2.85 (8.222)	1.86 (6.592)
Change at Day 15: 6 AM	1.81 (8.899)	-0.43 (7.595)
Change at Day 15: 8 AM	4.23 (8.180)	3.23 (9.857)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 8 AM: Analysis was based on analysis of covariance (ANCOVA) using statistical analysis system (SAS) mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.5330
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.07
	Confidence Interval	(2-Sided) 90%; -1.82 to 3.95
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 10 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.9532
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 90%; -4.13 to 3.85
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 12 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2493
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	2.53
	Confidence Interval	(2-Sided) 90%; -1.11 to 6.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 2 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2801
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-2.99
	Confidence Interval	(2-Sided) 90%; -7.59 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 4 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.9288
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.19
	Confidence Interval	(2-Sided) 90%; -3.77 to 3.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 6 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6459
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 90%; -2.62 to 4.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 8 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.0527
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	4.06
	Confidence Interval	(2-Sided) 90%; 0.63 to 7.48
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 14 10 PM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.1998
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	3.29
	Confidence Interval	(2-Sided) 90%; -0.95 to 7.52
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 15 12 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6765
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 90%; -4.22 to 2.53
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 15 4 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.6221
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 90%; -2.35 to 4.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 15 6 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3000
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	1.81
	Confidence Interval	(2-Sided) 90%; -1.11 to 4.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 15 8 AM: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.9103
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 90%; -3.85 to 3.37
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Number of Participants With Ocular and Systemic Adverse Events (AEs)
Description	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. Number of participants with ocular (AE related to eye) and systemic (all AEs including eye) AEs were reported.
Time Frame	Baseline up to 28 days after last dose of study medication (up to 58 Days)

Outcome Measure Data

Analysis Population Description

Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Ocular AEs	29 207.1%	25 156.3%
Systemic AEs	30 214.3%	28 175%

24. Secondary Outcome

Title	Percentage of Participants With Photophobia and Iritis
Description	Percentage of participants with treatment emergent photophobia (abnormal sensitivity or intolerance of eye towards light) and iritis (inflammation of the iris of eye) were reported. 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.
Time Frame	Baseline up to 28 days after last dose of study medication (up to 58 Days)

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Photophobia	83.33 595.2%	24.14 150.9%
Iritis	3.33 23.8%	6.90 43.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Photophobia: p-value was calculated using fisher exact test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	59.20
	Confidence Interval	(2-Sided) 95%; 38.69 to 79.70
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Iritis: p-value was calculated using fisher exact test.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.612
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Percent Difference
	Estimated Value	-3.56
	Confidence Interval	(2-Sided) 95%; -14.80 to 7.68
	Parameter Dispersion	Type: Value:
	Estimation Comments

25. Secondary Outcome

Title	Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35
Description	Corneal thickness was measured using an ultrasonic pachymeter. Corneal thickness in both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Time Frame	8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Day 1 8 AM: Baseline for study eye	562.8 (24.11)	561.0 (25.94)
Day 1 8 AM: Baseline for fellow eye	562.5 (24.86)	560.7 (28.36)
Change at Day 7 8 AM: study eye	26.6 (21.55)	25.0 (16.20)
Change at Day 7 8 AM: fellow eye	26.7 (19.81)	26.4 (18.12)
Change at Day 13 8 AM: study eye	20.2 (22.86)	21.2 (16.35)
Change at Day 13 8 AM: fellow eye	24.4 (19.63)	24.9 (20.42)
Change at Day 16 8 AM: study eye	20.7 (16.70)	19.7 (17.93)
Change at Day 16 8 AM: fellow eye	21.7 (18.77)	22.0 (18.41)
Change at Day 21 8 AM: study eye	5.7 (13.00)	8.9 (10.42)
Change at Day 21 8 AM: fellow eye	6.4 (10.09)	10.9 (13.38)
Change at Day 28 8 AM: study eye	7.8 (15.93)	6.9 (11.69)
Change at Day 28 8 AM: fellow eye	8.2 (9.20)	9.2 (9.88)
Change at Day 35 8 AM: study eye	2.3 (13.20)	5.4 (10.60)
Change at Day 35 8 AM: fellow eye	5.1 (10.99)	5.9 (12.79)

26. Secondary Outcome

Title	Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35
Description	Endothelial cell count was defined as the number of cells per millimeter square (cells/mm^2) of endothelium and was calculated using confocal microscopy for both study eye and fellow eye. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Time Frame	8 AM on Day 1 (Baseline), Day 13, 35

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received at least 1 dose of study medication. Here 'number analyzed' signifies those participants who were evaluable for this outcome measure at given time points, for each group respectively.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Day 1 8 AM: Baseline for study eye	2560.7 (501.79)	2585.3 (460.49)
Day 1 8 AM: Baseline for fellow eye	2456.5 (476.69)	2519.1 (440.66)
Change at Day 13 8 AM: study eye	-41.8 (162.76)	17.2 (192.40)
Change at Day 13 8 AM: fellow eye	29.5 (127.07)	-12.1 (130.47)
Change at Day 35 8 AM: study eye	-10.6 (140.50)	-45.3 (136.64)
Change at Day 35 8 AM: fellow eye	-12.6 (147.25)	-13.4 (122.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 13 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2450
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-52.42
	Confidence Interval	(2-Sided) 90%; -127.05 to 22.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 13 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.3068
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	34.51
	Confidence Interval	(2-Sided) 90%; -21.89 to 90.91
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 35 8 AM study eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.2632
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	40.99
	Confidence Interval	(2-Sided) 90%; -19.69 to 101.67
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Taprenepag+Latanoprost, Taprenepag+Latanoprost Vehicle
	Comments	Change at Day 35 8 AM fellow eye: Analysis was based on ANCOVA using SAS mixed procedure with covariates of baseline IOP, sequence, study period and treatment as fixed effects and participant within sequence as random effect.
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.8373
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-6.60
	Confidence Interval	(2-Sided) 90%; -60.84 to 47.64
	Parameter Dispersion	Type: Value:
	Estimation Comments

27. Other Pre-specified Outcome

Title	Maximum Conjunctival Hyperemia Score
Description	Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe). Higher score indicated severe condition. Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1). Highest conjunctival hyperemia score observed at Day -8 (baseline) and through Day 1 to 35 were reported. Maximum conjunctival hyperemia score for both study eye and fellow eye was reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Time Frame	Day -8 (Baseline), Day 1 to 35

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Day -8: Baseline for study eye	0.30 (0.466)	0.38 (0.494)
Day -8: Baseline for fellow eye	0.30 (0.466)	0.28 (0.455)
Day 1 to 35: study eye	1.87 (0.776)	1.45 (0.632)
Day 1 to 35: fellow eye	1.77 (0.898)	1.38 (0.728)

28. Other Pre-specified Outcome

Title	Change From Baseline in Maximum Conjunctival Hyperemia Score Observed
Description	Conjunctival hyperemia score was assessed using slit-lamp examination on a photographic reference scale ranging from 0 (normal) to 3 (severe). Conjunctival hyperemia was recorded to the nearest whole number using standard rounding rules (for example, a score of 1.5 was rounded up to 2 and a score of 1.4 was rounded down to 1). Change between highest conjunctival hyperemia score observed through Day 1 to 35 and highest conjunctival hyperemia score at baseline (Day -8) was reported. Maximum conjunctival hyperemia score for both study eye and fellow eye was reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and Day -8 was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Time Frame	Day -8 (Baseline), Day 1 to 35

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Change in study eye	1.57 (0.679)	1.07 (0.593)
Change in fellow eye	1.47 (0.860)	1.10 (0.673)

29. Other Pre-specified Outcome

Title	Total Corneal Staining Score
Description	Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Total corneal score from both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Time Frame	8 AM on Day 1 (Baseline)

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Day 1 8 AM: Baseline for study eye	0.1 (0.25)	0.0 (0.00)
Day 1 8 AM: Baseline for fellow eye	0.0 (0.18)	0.0 (0.00)

30. Other Pre-specified Outcome

Title	Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35
Description	Corneal staining was assessed using fluorescein dye, a yellow filter, and a slit lamp. The cornea was divided into 5 different zones. Each corneal zone was graded independently using a 0 to 3 grading scale; where 0= no staining, 1= scattered micropunctate staining (dots were discrete and countable), 2= areas of clustered micropunctate or one macropunctate stain, 3= areas of confluent micropunctate stain or two or more macropunctate stain or filaments. Sum of scores of each zone led to total score. Total score range: 0 to 15, higher score indicated greater staining. Total corneal score from both study eye and fellow eye were reported. Study eye: IOP was measured in both the eyes, and the eye with higher IOP reading across eligibility visit and baseline visit was referred as 'study eye'. If both the measurements were equal, right eye was selected as the study eye. The other eye was referred as 'fellow eye'.
Time Frame	8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35

Outcome Measure Data

Analysis Population Description

ITT population included all randomized participants who received at least 1 dose of study medication.

Arm/Group Title	Taprenepag+Latanoprost	Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.	Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
Measure Participants	30	29
Change at Day 7 8 AM: study eye	0.6 (1.28)	0.3 (0.81)
Change at Day 7 8 AM: fellow eye	0.5 (0.90)	0.4 (0.87)
Change at Day 13 8 AM: study eye	0.9 (1.44)	1.0 (1.48)
Change at Day 13 8 AM: fellow eye	0.9 (1.67)	1.0 (1.74)
Change at Day 16 8 AM: study eye	0.7 (1.49)	1.1 (1.48)
Change at Day 16 8 AM: fellow eye	0.8 (1.56)	0.9 (1.40)
Change at Day 21 8 AM: study eye	0.4 (0.81)	0.4 (0.90)
Change at Day 21 8 AM: fellow eye	0.4 (0.86)	0.2 (0.69)
Change at Day 28 8 AM: study eye	0.1 (0.61)	0.3 (0.65)
Change at Day 28 8 AM: fellow eye	0.1 (0.45)	0.0 (0.00)
Change at Day 35 8 AM: study eye	-0.0 (0.32)	0.0 (0.19)
Change at Day 35 8 AM: fellow eye	-0.0 (0.18)	0.0 (0.00)

Adverse Events

Time Frame	Baseline up to 28 days after last dose of study medication (up to 58 Days)
Adverse Event Reporting Description	ITT population, which included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title	Taprenepag+Latanoprost		Taprenepag+Latanoprost Vehicle
Arm/Group Description	Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.		Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period.
All Cause Mortality
	Taprenepag+Latanoprost		Taprenepag+Latanoprost Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Taprenepag+Latanoprost		Taprenepag+Latanoprost Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Taprenepag+Latanoprost		Taprenepag+Latanoprost Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	30/30 (100%)		28/29 (96.6%)
Eye disorders
Asthenopia	1/30 (3.3%)		0/29 (0%)
Conjunctival hyperaemia	13/30 (43.3%)		13/29 (44.8%)
Corneal disorder	23/30 (76.7%)		22/29 (75.9%)
Dry eye	1/30 (3.3%)		2/29 (6.9%)
Eye pain	5/30 (16.7%)		1/29 (3.4%)
Eye pruritus	1/30 (3.3%)		0/29 (0%)
Iritis	1/30 (3.3%)		2/29 (6.9%)
Lacrimation increased	0/30 (0%)		1/29 (3.4%)
Ocular hyperaemia	2/30 (6.7%)		0/29 (0%)
Photophobia	25/30 (83.3%)		7/29 (24.1%)
Vision blurred	3/30 (10%)		3/29 (10.3%)
Gastrointestinal disorders
Diarrhoea	1/30 (3.3%)		0/29 (0%)
General disorders
Instillation site pain	2/30 (6.7%)		1/29 (3.4%)
Sensation of foreign body	2/30 (6.7%)		0/29 (0%)
Immune system disorders
Food allergy	1/30 (3.3%)		0/29 (0%)
Infections and infestations
Fungal infection	0/30 (0%)		1/29 (3.4%)
Upper respiratory tract infection	3/30 (10%)		3/29 (10.3%)
Injury, poisoning and procedural complications
Arthropod bite	0/30 (0%)		1/29 (3.4%)
Contusion	1/30 (3.3%)		0/29 (0%)
Investigations
Blood potassium increased	1/30 (3.3%)		1/29 (3.4%)
Corneal staining	20/30 (66.7%)		20/29 (69%)
Musculoskeletal and connective tissue disorders
Costochondritis	1/30 (3.3%)		0/29 (0%)
Nervous system disorders
Headache	6/30 (20%)		5/29 (17.2%)
Sciatica	1/30 (3.3%)		1/29 (3.4%)
Reproductive system and breast disorders
Uterine prolapse	1/30 (3.3%)		1/29 (3.4%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	1/30 (3.3%)		1/29 (3.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.