Glaucoma, Open-Angle, Ocular Hypertension
Conditions
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.
Interventions
DRUGPF-04217329
Topical ocular solution, once-daily for 14 days
Topical ocular solution, once-daily for 14 days
DRUGlatanoprost
Topical ocular solution, once-daily for 14 days
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14 | 1 hour post-dose on Day 14 | — |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14 | 5 minutes post-dose on Day 14 | — |
| Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14 | 0.25 hours post-dose on Day 14 | — |
| Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14 | 0.5 hours post-dose on Day 14 | — |
| Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14 | 0.75 hours post-dose on Day 14 | — |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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'. |
| 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'. |
| 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. |
| 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). |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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'. |
| 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'. |
| 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'. |
| 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'. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle 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. | 14 |
| Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost 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. | 16 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention Period (14 Days) | Randomized, but not treated | 1 | 0 |
| First Intervention Period (14 Days) | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Taprenepag+Latanoprost, Then Taprenepag+Latanoprost Vehicle | Taprenepag+Latanoprost Vehicle,Then Taprenepag+Latanoprost | Total |
|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 9 | 65.2 years STANDARD_DEVIATION 11.3 | 66.6 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 22 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 30 / 30 | 28 / 29 |
| serious Total, serious adverse events | 0 / 30 | 0 / 29 |
Outcome results
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (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.
Time frame: 10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Baseline (Day -8): 10 AM | 21.40 mmHg | Standard Deviation 3.022 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Change at Day 14: 10 AM | 3.90 mmHg | Standard Deviation 2.445 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Baseline (Day -8): 10 AM | 20.82 mmHg | Standard Deviation 2.385 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 AM (2 Hours) | Change at Day 14: 10 AM | 3.09 mmHg | Standard Deviation 2.822 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (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.
Time frame: 10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) | Baseline (Day -8): 10 PM | 18.25 mmHg | Standard Deviation 2.978 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) | Change at Day 14: 10 PM | 5.40 mmHg | Standard Deviation 3.365 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) | Baseline (Day -8): 10 PM | 17.96 mmHg | Standard Deviation 3.347 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 10 PM (14 Hours) | Change at Day 14: 10 PM | 3.88 mmHg | Standard Deviation 3.693 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (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.
Time frame: 12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | Baseline (Day -8): 12 PM | 21.54 mmHg | Standard Deviation 3.514 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | Change at Day 14: 12 PM | 5.15 mmHg | Standard Deviation 2.482 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | Baseline (Day -8): 12 PM | 21.45 mmHg | Standard Deviation 2.518 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 12 Post Meridiem (PM) (4 Hours) | Change at Day 14: 12 PM | 4.43 mmHg | Standard Deviation 2.53 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (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.
Time frame: 2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) | Baseline (Day -8): 2 PM | 22.25 mmHg | Standard Deviation 2.766 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) | Change at Day 14: 2 PM | 6.56 mmHg | Standard Deviation 2.438 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) | Baseline (Day -8): 2 PM | 20.80 mmHg | Standard Deviation 2.601 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 2 PM (6 Hours) | Change at Day 14: 2 PM | 3.91 mmHg | Standard Deviation 2.5 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (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.
Time frame: 4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours)
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) | Baseline (Day -8): 4 PM | 18.56 mmHg | Standard Deviation 3.383 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) | Change at Day 14: 4 PM | 5.79 mmHg | Standard Deviation 3.333 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) | Baseline (Day -8): 4 PM | 17.68 mmHg | Standard Deviation 3.403 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 4 PM (8 Hours) | Change at Day 14: 4 PM | 4.50 mmHg | Standard Deviation 3.611 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (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.
Time frame: 6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) | Baseline (Day -8): 6 PM | 19.10 mmHg | Standard Deviation 3.369 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) | Change at Day 14: 6 PM | 6.42 mmHg | Standard Deviation 4.655 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) | Baseline (Day -8): 6 PM | 17.29 mmHg | Standard Deviation 3.326 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 6 PM (10 Hours) | Change at Day 14: 6 PM | 3.95 mmHg | Standard Deviation 3.417 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (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.
Time frame: 8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour)
Population: Per-protocol (PP) population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Baseline (Day -8) : 8 AM | 22.77 mmHg | Standard Deviation 3.264 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Change at Day 14: 8 AM | 5.00 mmHg | Standard Deviation 2.391 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Baseline (Day -8) : 8 AM | 22.41 mmHg | Standard Deviation 2.786 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 Ante Meridiem (AM) (0 Hour) | Change at Day 14: 8 AM | 3.79 mmHg | Standard Deviation 2.942 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (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.
Time frame: 8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) | Baseline (Day -8) for Day 14 : 8 PM | 18.58 mmHg | Standard Deviation 3.79 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) | Change at Day 14: 8 PM | 6.44 mmHg | Standard Deviation 4.22 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) | Baseline (Day -8) for Day 14 : 8 PM | 16.66 mmHg | Standard Deviation 3.483 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 14: 8 PM (12 Hours) | Change at Day 14: 8 PM | 3.30 mmHg | Standard Deviation 3.425 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (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.
Time frame: 12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) | Baseline (Day -7): 12 AM | 17.98 mmHg | Standard Deviation 3.58 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) | Change at Day 15: 12 AM | 5.71 mmHg | Standard Deviation 2.4 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) | Baseline (Day -7): 12 AM | 16.77 mmHg | Standard Deviation 3.77 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 12 AM (16 Hours) | Change at Day 15: 12 AM | 4.34 mmHg | Standard Deviation 3.443 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (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.
Time frame: 4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) | Baseline (Day -7) : 4 AM | 16.77 mmHg | Standard Deviation 3.742 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) | Change at Day 15: 4 AM | 4.31 mmHg | Standard Deviation 3.978 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) | Baseline (Day -7) : 4 AM | 16.66 mmHg | Standard Deviation 2.941 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 4 AM (20 Hours) | Change at Day 15: 4 AM | 4.39 mmHg | Standard Deviation 2.551 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (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.
Time frame: 6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours) | Baseline (Day -7): 6 AM | 17.98 mmHg | Standard Deviation 3.952 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours) | Change at Day 15: 6 AM | 5.02 mmHg | Standard Deviation 4.415 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours) | Baseline (Day -7): 6 AM | 17.36 mmHg | Standard Deviation 2.785 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 6 AM (22 Hours) | Change at Day 15: 6 AM | 4.32 mmHg | Standard Deviation 2.878 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (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.
Time frame: 8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours) | Baseline (Day -7): 8 AM | 23.31 mmHg | Standard Deviation 2.497 |
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours) | Change at Day 15: 8 AM | 6.19 mmHg | Standard Deviation 2.801 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours) | Baseline (Day -7): 8 AM | 22.71 mmHg | Standard Deviation 2.347 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 15: 8 AM (24 Hours) | Change at Day 15: 8 AM | 4.77 mmHg | Standard Deviation 2.518 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (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.
Time frame: 8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours) | 1.21 mmHg | Standard Deviation 5.009 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 16: 8 AM (48 Hours) | -0.20 mmHg | Standard Deviation 3.023 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (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.
Time frame: 8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours)
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours) | 0.89 mmHg | Standard Deviation 3.769 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 17: 8 AM (72 Hours) | -0.95 mmHg | Standard Deviation 3.563 |
Primary
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (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.
Time frame: 8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours)
Population: PP population included all participants who completed the study treatment with no major protocol violations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours) | -0.19 mmHg | Standard Deviation 3.017 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 21: 8 AM (168 Hours) | -0.36 mmHg | Standard Deviation 3.197 |
Primary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14 | 67.23 pg/mL | Standard Deviation 33.885 |
| Taprenepag+Latanoprost Vehicle | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14 | 88.65 pg/mL | Standard Deviation 54.679 |
Primary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14 | 47.88 pg/mL | Standard Deviation 29.811 |
| Taprenepag+Latanoprost Vehicle | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14 | 53.07 pg/mL | Standard Deviation 34.336 |
Primary
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
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14 | 31.68 pg/mL | Standard Deviation 20.692 |
| Taprenepag+Latanoprost Vehicle | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14 | 30.74 pg/mL | Standard Deviation 18.726 |
Primary
Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14
Time frame: 1 hour post-dose on Day 14
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14 | 24.94 pg/mL | Standard Deviation 25.301 |
| Taprenepag+Latanoprost Vehicle | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14 | 18.96 pg/mL | Standard Deviation 14.827 |
Primary
Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14
Time frame: 5 minutes post-dose on Day 14
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Taprenepag+Latanoprost | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14 | 36.20 pg/mL | Standard Deviation 23.847 |
| Taprenepag+Latanoprost Vehicle | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14 | 43.27 pg/mL | Standard Deviation 36.29 |
Secondary
Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 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'.
Time frame: 8 AM on Day 1 (Baseline), Day 13, 35
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Day 1 8 AM: Baseline for fellow eye | 2456.5 cells/mm^2 | Standard Deviation 476.69 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 13 8 AM: fellow eye | 29.5 cells/mm^2 | Standard Deviation 127.07 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Day 1 8 AM: Baseline for study eye | 2560.7 cells/mm^2 | Standard Deviation 501.79 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 35 8 AM: study eye | -10.6 cells/mm^2 | Standard Deviation 140.5 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 35 8 AM: fellow eye | -12.6 cells/mm^2 | Standard Deviation 147.25 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 13 8 AM: study eye | -41.8 cells/mm^2 | Standard Deviation 162.76 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 35 8 AM: fellow eye | -13.4 cells/mm^2 | Standard Deviation 122.5 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Day 1 8 AM: Baseline for study eye | 2585.3 cells/mm^2 | Standard Deviation 460.49 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Day 1 8 AM: Baseline for fellow eye | 2519.1 cells/mm^2 | Standard Deviation 440.66 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 13 8 AM: study eye | 17.2 cells/mm^2 | Standard Deviation 192.4 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 13 8 AM: fellow eye | -12.1 cells/mm^2 | Standard Deviation 130.47 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Endothelial Cell Counts at Day 13 and 35 | Change at Day 35 8 AM: study eye | -45.3 cells/mm^2 | Standard Deviation 136.64 |
Comparison: 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.p-value: 0.24590% CI: [-127.05, 22.22]ANCOVA
Comparison: 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.p-value: 0.306890% CI: [-21.89, 90.91]ANCOVA
Comparison: 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.p-value: 0.263290% CI: [-19.69, 101.67]ANCOVA
Comparison: 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.p-value: 0.837390% CI: [-60.84, 47.64]ANCOVA
Secondary
Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 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'.
Time frame: 8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Day 1 8 AM: Baseline for study eye | 562.8 micrometer | Standard Deviation 24.11 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Day 1 8 AM: Baseline for fellow eye | 562.5 micrometer | Standard Deviation 24.86 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: study eye | 26.6 micrometer | Standard Deviation 21.55 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: fellow eye | 26.7 micrometer | Standard Deviation 19.81 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: study eye | 20.2 micrometer | Standard Deviation 22.86 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: fellow eye | 24.4 micrometer | Standard Deviation 19.63 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: study eye | 20.7 micrometer | Standard Deviation 16.7 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: fellow eye | 21.7 micrometer | Standard Deviation 18.77 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: study eye | 5.7 micrometer | Standard Deviation 13 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: fellow eye | 6.4 micrometer | Standard Deviation 10.09 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: study eye | 7.8 micrometer | Standard Deviation 15.93 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: fellow eye | 8.2 micrometer | Standard Deviation 9.2 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: study eye | 2.3 micrometer | Standard Deviation 13.2 |
| Taprenepag+Latanoprost | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: fellow eye | 5.1 micrometer | Standard Deviation 10.99 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: study eye | 6.9 micrometer | Standard Deviation 11.69 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Day 1 8 AM: Baseline for study eye | 561.0 micrometer | Standard Deviation 25.94 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: fellow eye | 22.0 micrometer | Standard Deviation 18.41 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Day 1 8 AM: Baseline for fellow eye | 560.7 micrometer | Standard Deviation 28.36 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: study eye | 5.4 micrometer | Standard Deviation 10.6 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: study eye | 25.0 micrometer | Standard Deviation 16.2 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: study eye | 8.9 micrometer | Standard Deviation 10.42 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: fellow eye | 26.4 micrometer | Standard Deviation 18.12 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: fellow eye | 9.2 micrometer | Standard Deviation 9.88 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: study eye | 21.2 micrometer | Standard Deviation 16.35 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: fellow eye | 10.9 micrometer | Standard Deviation 13.38 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: fellow eye | 24.9 micrometer | Standard Deviation 20.42 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: fellow eye | 5.9 micrometer | Standard Deviation 12.79 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Corneal Thickness at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: study eye | 19.7 micrometer | Standard Deviation 17.93 |
Secondary
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)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 8 PM (n=24,28) | 52.50 mmHg | Standard Deviation 15.829 |
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 10 AM(n=24,28) | 46.06 mmHg | Standard Deviation 10.862 |
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 12 PM (n=24,28) | 47.29 mmHg | Standard Deviation 10.917 |
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 2 PM (n=24,28) | 46.75 mmHg | Standard Deviation 10.26 |
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 4 PM (n=24,28) | 53.98 mmHg | Standard Deviation 13.218 |
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 6 PM (n=24,28) | 53.98 mmHg | Standard Deviation 12.883 |
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 8 AM (n=24,28) | 52.81 mmHg | Standard Deviation 11.179 |
| Taprenepag+Latanoprost | 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) | Day -8: Baseline for Day 14 10 PM (n=24,28) | 46.54 mmHg | Standard Deviation 9.894 |
| Taprenepag+Latanoprost | 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) | Day -7: Baseline for Day 15 12 AM (n=24,28) | 48.73 mmHg | Standard Deviation 9.88 |
| Taprenepag+Latanoprost | 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) | Day -7: Baseline for Day 15 4 AM (n=24,28) | 51.98 mmHg | Standard Deviation 12.386 |
| Taprenepag+Latanoprost | 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) | Day -7: Baseline for Day 15: 6 AM | 53.60 mmHg | Standard Deviation 13.672 |
| Taprenepag+Latanoprost | 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) | Day -7: Baseline for Day 15: 8 AM | 52.94 mmHg | Standard Deviation 10.584 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 8 AM | 5.38 mmHg | Standard Deviation 8.403 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 10 AM | 2.77 mmHg | Standard Deviation 9.336 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 12 PM | 6.65 mmHg | Standard Deviation 8.906 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 2 PM | 4.15 mmHg | Standard Deviation 12.645 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 4 PM | 3.25 mmHg | Standard Deviation 13.492 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 6 PM | 6.00 mmHg | Standard Deviation 10.208 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 8 PM | 6.94 mmHg | Standard Deviation 11.9 |
| Taprenepag+Latanoprost | 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) | Change at Day 14: 10 PM | 5.73 mmHg | Standard Deviation 10.332 |
| Taprenepag+Latanoprost | 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) | Change at Day 15: 12 AM | 3.04 mmHg | Standard Deviation 6.716 |
| Taprenepag+Latanoprost | 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) | Change at Day 15: 4 AM | 2.85 mmHg | Standard Deviation 8.222 |
| Taprenepag+Latanoprost | 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) | Change at Day 15: 6 AM | 1.81 mmHg | Standard Deviation 8.899 |
| Taprenepag+Latanoprost | 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) | Change at Day 15: 8 AM | 4.23 mmHg | Standard Deviation 8.18 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 15: 6 AM | -0.43 mmHg | Standard Deviation 7.595 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 8 AM (n=24,28) | 53.05 mmHg | Standard Deviation 13.183 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 8 AM | 4.43 mmHg | Standard Deviation 7.262 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 10 AM(n=24,28) | 44.57 mmHg | Standard Deviation 13.493 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 8 PM | 2.16 mmHg | Standard Deviation 8.423 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 12 PM (n=24,28) | 50.34 mmHg | Standard Deviation 11.341 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 10 AM | 3.70 mmHg | Standard Deviation 11.108 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 2 PM (n=24,28) | 46.13 mmHg | Standard Deviation 9.988 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 15: 4 AM | 1.86 mmHg | Standard Deviation 6.592 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 4 PM (n=24,28) | 52.39 mmHg | Standard Deviation 10.495 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 12 PM | 2.82 mmHg | Standard Deviation 8.79 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 6 PM (n=24,28) | 58.14 mmHg | Standard Deviation 12.28 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 10 PM | 2.05 mmHg | Standard Deviation 10.401 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 8 PM (n=24,28) | 53.77 mmHg | Standard Deviation 13.349 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 2 PM | 7.31 mmHg | Standard Deviation 7.558 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -8: Baseline for Day 14 10 PM (n=24,28) | 47.79 mmHg | Standard Deviation 14.196 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 15: 8 AM | 3.23 mmHg | Standard Deviation 9.857 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -7: Baseline for Day 15 12 AM (n=24,28) | 49.73 mmHg | Standard Deviation 11.843 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 4 PM | 3.98 mmHg | Standard Deviation 7.597 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -7: Baseline for Day 15 4 AM (n=24,28) | 51.73 mmHg | Standard Deviation 10.801 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 15: 12 AM | 3.80 mmHg | Standard Deviation 8.231 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -7: Baseline for Day 15: 6 AM | 54.39 mmHg | Standard Deviation 13.151 |
| Taprenepag+Latanoprost Vehicle | 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) | Change at Day 14: 6 PM | 2.59 mmHg | Standard Deviation 10.723 |
| Taprenepag+Latanoprost Vehicle | 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) | Day -7: Baseline for Day 15: 8 AM | 55.18 mmHg | Standard Deviation 11.923 |
Comparison: 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.p-value: 0.53390% CI: [-1.82, 3.95]ANCOVA
Comparison: 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.p-value: 0.953290% CI: [-4.13, 3.85]ANCOVA
Comparison: 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.p-value: 0.249390% CI: [-1.11, 6.18]ANCOVA
Comparison: 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.p-value: 0.280190% CI: [-7.59, 1.6]ANCOVA
Comparison: 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.p-value: 0.928890% CI: [-3.77, 3.39]ANCOVA
Comparison: 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.p-value: 0.645990% CI: [-2.62, 4.58]ANCOVA
Comparison: 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.p-value: 0.052790% CI: [0.63, 7.48]ANCOVA
Comparison: 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.p-value: 0.199890% CI: [-0.95, 7.52]ANCOVA
Comparison: 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.p-value: 0.676590% CI: [-4.22, 2.53]ANCOVA
Comparison: 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.p-value: 0.622190% CI: [-2.35, 4.33]ANCOVA
Comparison: 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.p-value: 0.390% CI: [-1.11, 4.74]ANCOVA
Comparison: 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.p-value: 0.910390% CI: [-3.85, 3.37]ANCOVA
Secondary
Diastolic Ocular Perfusion Pressure (DOPP)
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
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 8AM | 57.42 mmHg | Standard Deviation 8.984 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 10AM | 48.28 mmHg | Standard Deviation 10.902 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 12PM | 52.70 mmHg | Standard Deviation 10.289 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 2PM | 49.73 mmHg | Standard Deviation 12.744 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 4PM | 56.73 mmHg | Standard Deviation 9.555 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 6PM | 59.38 mmHg | Standard Deviation 9.527 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 8PM | 58.18 mmHg | Standard Deviation 10.929 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 10PM | 51.57 mmHg | Standard Deviation 12.317 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 12AM | 51.10 mmHg | Standard Deviation 10.247 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 4AM | 54.25 mmHg | Standard Deviation 11.929 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 6AM | 54.08 mmHg | Standard Deviation 11.784 |
| Taprenepag+Latanoprost | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 8AM | 57.32 mmHg | Standard Deviation 10.431 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 6AM | 53.90 mmHg | Standard Deviation 11.385 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 8AM | 57.48 mmHg | Standard Deviation 12.1 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 8PM | 55.98 mmHg | Standard Deviation 10.351 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 10AM | 48.29 mmHg | Standard Deviation 10.652 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 4AM | 54.00 mmHg | Standard Deviation 11.168 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 12PM | 52.84 mmHg | Standard Deviation 10.105 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 10PM | 49.86 mmHg | Standard Deviation 10.419 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 2PM | 52.52 mmHg | Standard Deviation 10.908 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 8AM | 58.47 mmHg | Standard Deviation 10.941 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 4PM | 56.75 mmHg | Standard Deviation 9.776 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 15: 12AM | 53.52 mmHg | Standard Deviation 12.302 |
| Taprenepag+Latanoprost Vehicle | Diastolic Ocular Perfusion Pressure (DOPP) | Day 14: 6PM | 60.41 mmHg | Standard Deviation 9.809 |
Secondary
Number of Participants With Ocular and Systemic Adverse Events (AEs)
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)
Population: Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Taprenepag+Latanoprost | Number of Participants With Ocular and Systemic Adverse Events (AEs) | Ocular AEs | 29 Participants |
| Taprenepag+Latanoprost | Number of Participants With Ocular and Systemic Adverse Events (AEs) | Systemic AEs | 30 Participants |
| Taprenepag+Latanoprost Vehicle | Number of Participants With Ocular and Systemic Adverse Events (AEs) | Ocular AEs | 25 Participants |
| Taprenepag+Latanoprost Vehicle | Number of Participants With Ocular and Systemic Adverse Events (AEs) | Systemic AEs | 28 Participants |
Secondary
Percentage of Participants With Photophobia and Iritis
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)
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Taprenepag+Latanoprost | Percentage of Participants With Photophobia and Iritis | Photophobia | 83.33 percentage of participants |
| Taprenepag+Latanoprost | Percentage of Participants With Photophobia and Iritis | Iritis | 3.33 percentage of participants |
| Taprenepag+Latanoprost Vehicle | Percentage of Participants With Photophobia and Iritis | Photophobia | 24.14 percentage of participants |
| Taprenepag+Latanoprost Vehicle | Percentage of Participants With Photophobia and Iritis | Iritis | 6.90 percentage of participants |
Comparison: Photophobia: p-value was calculated using fisher exact test.p-value: <0.00195% CI: [38.69, 79.7]Fisher Exact
Comparison: Iritis: p-value was calculated using fisher exact test.p-value: 0.61295% CI: [-14.8, 7.68]Fisher Exact
Other Pre-specified
Change From Baseline in Maximum Conjunctival Hyperemia Score Observed
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
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Maximum Conjunctival Hyperemia Score Observed | Change in study eye | 1.57 units on a scale | Standard Deviation 0.679 |
| Taprenepag+Latanoprost | Change From Baseline in Maximum Conjunctival Hyperemia Score Observed | Change in fellow eye | 1.47 units on a scale | Standard Deviation 0.86 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Maximum Conjunctival Hyperemia Score Observed | Change in study eye | 1.07 units on a scale | Standard Deviation 0.593 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Maximum Conjunctival Hyperemia Score Observed | Change in fellow eye | 1.10 units on a scale | Standard Deviation 0.673 |
Other Pre-specified
Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 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'.
Time frame: 8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: study eye | 0.6 units on a scale | Standard Deviation 1.28 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: fellow eye | 0.5 units on a scale | Standard Deviation 0.9 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: study eye | 0.9 units on a scale | Standard Deviation 1.44 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: fellow eye | 0.9 units on a scale | Standard Deviation 1.67 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: study eye | 0.7 units on a scale | Standard Deviation 1.49 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: fellow eye | 0.8 units on a scale | Standard Deviation 1.56 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: study eye | 0.4 units on a scale | Standard Deviation 0.81 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: fellow eye | 0.4 units on a scale | Standard Deviation 0.86 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: study eye | 0.1 units on a scale | Standard Deviation 0.61 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: fellow eye | 0.1 units on a scale | Standard Deviation 0.45 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: study eye | -0.0 units on a scale | Standard Deviation 0.32 |
| Taprenepag+Latanoprost | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: fellow eye | -0.0 units on a scale | Standard Deviation 0.18 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: study eye | 0.0 units on a scale | Standard Deviation 0.19 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: study eye | 0.3 units on a scale | Standard Deviation 0.81 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: study eye | 0.4 units on a scale | Standard Deviation 0.9 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 7 8 AM: fellow eye | 0.4 units on a scale | Standard Deviation 0.87 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: fellow eye | 0.0 units on a scale | Standard Deviation 0 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: study eye | 1.0 units on a scale | Standard Deviation 1.48 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 21 8 AM: fellow eye | 0.2 units on a scale | Standard Deviation 0.69 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 13 8 AM: fellow eye | 1.0 units on a scale | Standard Deviation 1.74 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 35 8 AM: fellow eye | 0.0 units on a scale | Standard Deviation 0 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: study eye | 1.1 units on a scale | Standard Deviation 1.48 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 28 8 AM: study eye | 0.3 units on a scale | Standard Deviation 0.65 |
| Taprenepag+Latanoprost Vehicle | Change From Baseline in Total Corneal Staining Score at Day 7, 13, 16, 21, 28 and 35 | Change at Day 16 8 AM: fellow eye | 0.9 units on a scale | Standard Deviation 1.4 |
Other Pre-specified
Maximum Conjunctival Hyperemia Score
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
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Maximum Conjunctival Hyperemia Score | Day -8: Baseline for study eye | 0.30 units on a scale | Standard Deviation 0.466 |
| Taprenepag+Latanoprost | Maximum Conjunctival Hyperemia Score | Day -8: Baseline for fellow eye | 0.30 units on a scale | Standard Deviation 0.466 |
| Taprenepag+Latanoprost | Maximum Conjunctival Hyperemia Score | Day 1 to 35: study eye | 1.87 units on a scale | Standard Deviation 0.776 |
| Taprenepag+Latanoprost | Maximum Conjunctival Hyperemia Score | Day 1 to 35: fellow eye | 1.77 units on a scale | Standard Deviation 0.898 |
| Taprenepag+Latanoprost Vehicle | Maximum Conjunctival Hyperemia Score | Day 1 to 35: fellow eye | 1.38 units on a scale | Standard Deviation 0.728 |
| Taprenepag+Latanoprost Vehicle | Maximum Conjunctival Hyperemia Score | Day -8: Baseline for study eye | 0.38 units on a scale | Standard Deviation 0.494 |
| Taprenepag+Latanoprost Vehicle | Maximum Conjunctival Hyperemia Score | Day 1 to 35: study eye | 1.45 units on a scale | Standard Deviation 0.632 |
| Taprenepag+Latanoprost Vehicle | Maximum Conjunctival Hyperemia Score | Day -8: Baseline for fellow eye | 0.28 units on a scale | Standard Deviation 0.455 |
Other Pre-specified
Total Corneal Staining Score
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)
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag+Latanoprost | Total Corneal Staining Score | Day 1 8 AM: Baseline for study eye | 0.1 units on a scale | Standard Deviation 0.25 |
| Taprenepag+Latanoprost | Total Corneal Staining Score | Day 1 8 AM: Baseline for fellow eye | 0.0 units on a scale | Standard Deviation 0.18 |
| Taprenepag+Latanoprost Vehicle | Total Corneal Staining Score | Day 1 8 AM: Baseline for study eye | 0.0 units on a scale | Standard Deviation 0 |
| Taprenepag+Latanoprost Vehicle | Total Corneal Staining Score | Day 1 8 AM: Baseline for fellow eye | 0.0 units on a scale | Standard Deviation 0 |