| 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. | Per-protocol (PP) population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 8 AM on Baseline (Day -8), 8 AM on Day 14 (0 Hour) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
| | | Title | Denominators | Categories |
|---|
| Baseline (Day -8) : 8 AM | | | Title | Measurements |
|---|
| - OG00022.77± 3.264
- OG00122.41± 2.786
|
| | Change at Day 14: 8 AM | | |
| |
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 10 AM on Baseline (Day -8), 10 AM on Day 14 (2 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
|
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 12 PM on Baseline (Day -8), 12 PM on Day 14 (4 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 2 PM on Baseline (Day -8), 2 PM on Day 14 (6 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
|
| 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 4 PM on Baseline (Day -8), 4 PM on Day 14 (8 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
|
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 6 PM on Baseline (Day -8), 6 PM on Day 14 (10 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
|
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 8 PM on Baseline (Day -8), 8 PM on Day 14 (12 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
|
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 10 PM on Day -8 (Baseline), 10 PM on Day 14 (14 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
|
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 12 AM on Baseline (Day -7), 12 AM on Day 15 (16 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
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| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 4 AM on Baseline (Day -7), 4 AM on Day 15 (20 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
|
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 6 AM on Baseline (Day -7), 6 AM on Day 15 (22 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
|
| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 8 AM on Baseline (Day -7), 8 AM on Day 15 (24 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
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| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 8 AM on Baseline (Day -8), 8 AM on Day 16 (48 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 8 AM on Baseline (Day -8), 8 AM on Day 17 (72 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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. | PP population included all participants who completed the study treatment with no major protocol violations. | Posted | | Mean | Standard Deviation | mmHg | | 8 AM on Day -8 (Baseline), 8 AM on Day 21 (168 Hours) | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | |
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| Primary | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 5 Minutes on Day 14 | | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 5 minutes post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| Primary | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.25 Hours on Day 14 | | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 0.25 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| Primary | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.5 Hours on Day 14 | | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 0.5 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| Primary | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 0.75 Hours on Day 14 | | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 0.75 hours post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| Primary | Plasma Concentration for PF-04217329 Active Metabolite (CP-544326) at 1 Hour on Day 14 | | 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. | Posted | | Mean | Standard Deviation | pg/mL | | 1 hour post-dose on Day 14 | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | mmHg | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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). | 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. | Posted | | Mean | Standard Deviation | mmHg | | 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 | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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. | Intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study medication. | Posted | | Count of Participants | | Participants | | Baseline up to 28 days after last dose of study medication (up to 58 Days) | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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. | ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | | Number | | percentage of participants | | Baseline up to 28 days after last dose of study medication (up to 58 Days) | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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'. | ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | micrometer | | 8 AM on Day 1 (Baseline), Days 7, 13, 16, 21, 28, 35 | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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'. | 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. | Posted | | Mean | Standard Deviation | cells/mm^2 | | 8 AM on Day 1 (Baseline), Day 13, 35 | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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'. | ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day -8 (Baseline), Day 1 to 35 | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. |
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| 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'. | ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | units on a scale | | Day -8 (Baseline), Day 1 to 35 | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle | |
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| 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'. | ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | units on a scale | | 8 AM on Day 1 (Baseline) | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle |
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| 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'. | ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | | Mean | Standard Deviation | units on a scale | | 8 AM Day 1 (Baseline), Day 7, 13, 16, 21, 28, 35 | | | | ID | Title | Description |
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| OG000 | Taprenepag+Latanoprost | Participants self-administered 1 drop (27 mcL) of latanoprost 0.005 percent (%) ophthalmic solution followed by taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in either first intervention period or second intervention period. | | OG001 | Taprenepag+Latanoprost Vehicle |
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