Primary Open-Angle Glaucoma, Ocular Hypertension
Conditions
Keywords
Open-Angle Glaucoma, Ocular Hypertension
Brief summary
To evaluate the safety and efficacy of PF-04217329.
Interventions
1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Sponsors
Study design
Eligibility
Inclusion criteria
* Diagnosis of primary open-angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in 1 or both eyes. * Qualifying intraocular pressure (IOP) in the same eye at the Eligibility 1 and 2 measurements.
Exclusion criteria
* Closed/barely open anterior chamber angle or a history of acute angle closure in either eye. * Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Stage I: Baseline, Day 14 | Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14. |
| Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Stage II: Baseline, Day 28 | Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28. |
| Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 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. Ocular AEs were the events which were localized in the ocular region. |
| Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days) | An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14). |
| Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. |
| Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28 | IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28). |
| Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | Stage I: Day 1 up to Day 14 | Percentage of participants who reached an IOP of less than or equal to (\<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer. |
| Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | Stage II: Day 1 up to Day 28 | Percentage of participants who reached an IOP \<= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Taprenepag 0.0025% (Stage I) Participants self-administered 1 drop (27 microliter \[mcL\]) of taprenepag (taprenepag isopropyl, PF-04217329) 0.0025 percent (%) ophthalmic solution into each eye once daily for 14 days in Stage I. | 9 |
| Taprenepag 0.005% (Stage I) Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution into each eye once daily for 14 days in Stage I. | 9 |
| Taprenepag 0.01% (Stage I) Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution into each eye once daily for 14 days in Stage I. | 9 |
| Taprenepag 0.015% (Stage I) Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution into each eye once daily for 14 days in Stage I. | 10 |
| Taprenepag 0.02% (Stage I) Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.02% ophthalmic solution into each eye once daily for 14 days in Stage I. | 9 |
| Taprenepag 0.03% (Stage I) Participants self-administered 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.03% ophthalmic solution into each eye once daily for 14 days in Stage I. | 9 |
| Taprenepag Vehicle (Stage I) Participants self-administered 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution into each eye once daily for 14 days in Stage I. | 12 |
| Latanoprost Vehicle and Taprenepag 0.005% (Stage II) Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II. | 35 |
| Latanoprost Vehicle and Taprenepag 0.01% (Stage II) Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II. | 36 |
| Latanoprost Vehicle and Taprenepag 0.015% (Stage II) Participants self-administered 1 drop (27 mcL) of vehicle matched to latanoprost ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II. | 36 |
| Latanoprost 0.005% and Taprenepag 0.005% (Stage II) Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.005% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II. | 36 |
| Latanoprost 0.005% and Taprenepag 0.01% (Stage II) Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.01% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II. | 36 |
| Latanoprost 0.005% and Taprenepag 0.015% (Stage II) Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of taprenepag (taprenepag isopropyl, PF-04217329) 0.015% ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II. | 36 |
| Latanoprost 0.005% and Taprenepag Vehicle (Stage II) Participants self-administered 1 drop (27 mcL) of latanoprost 0.005% ophthalmic solution followed by 1 drop (27 mcL) of vehicle matched to taprenepag (taprenepag isopropyl, PF-04217329) ophthalmic solution after 5 minutes, into each eye once daily for 28 days in Stage II. | 35 |
| Total | 317 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Stage I (14 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage I (14 Days) | Other | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Stage II (28 Days) | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 3 | 3 | 4 | 5 | 1 |
| Stage II (28 Days) | Death | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Stage II (28 Days) | Other | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Stage II (28 Days) | Randomized, but not treated | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
| Stage II (28 Days) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | Taprenepag 0.0025% (Stage I) | Taprenepag 0.005% (Stage I) | Taprenepag 0.01% (Stage I) | Taprenepag 0.015% (Stage I) | Taprenepag 0.02% (Stage I) | Taprenepag 0.03% (Stage I) | Taprenepag Vehicle (Stage I) | Latanoprost Vehicle and Taprenepag 0.005% (Stage II) | Latanoprost Vehicle and Taprenepag 0.01% (Stage II) | Latanoprost Vehicle and Taprenepag 0.015% (Stage II) | Latanoprost 0.005% and Taprenepag 0.005% (Stage II) | Latanoprost 0.005% and Taprenepag 0.01% (Stage II) | Latanoprost 0.005% and Taprenepag 0.015% (Stage II) | Latanoprost 0.005% and Taprenepag Vehicle (Stage II) | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 59.1 years STANDARD_DEVIATION 13 | 59.1 years STANDARD_DEVIATION 8.1 | 64.1 years STANDARD_DEVIATION 6.8 | 51.8 years STANDARD_DEVIATION 10.4 | 64.6 years STANDARD_DEVIATION 9.6 | 60.3 years STANDARD_DEVIATION 8.5 | 62.1 years STANDARD_DEVIATION 6.5 | 62.5 years STANDARD_DEVIATION 10.7 | 63.8 years STANDARD_DEVIATION 11.4 | 66.6 years STANDARD_DEVIATION 10.1 | 66.7 years STANDARD_DEVIATION 11.4 | 64.1 years STANDARD_DEVIATION 9.1 | 63.7 years STANDARD_DEVIATION 9.4 | 68.9 years STANDARD_DEVIATION 10.2 | 64.1 years STANDARD_DEVIATION 10.5 |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 6 Participants | 10 Participants | 3 Participants | 6 Participants | 8 Participants | 25 Participants | 22 Participants | 21 Participants | 24 Participants | 25 Participants | 21 Participants | 22 Participants | 204 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 3 Participants | 0 Participants | 6 Participants | 3 Participants | 4 Participants | 10 Participants | 14 Participants | 15 Participants | 12 Participants | 11 Participants | 15 Participants | 13 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 9 | 3 / 9 | 0 / 9 | 5 / 10 | 5 / 9 | 9 / 9 | 4 / 12 | 18 / 35 | 20 / 36 | 27 / 36 | 24 / 36 | 27 / 36 | 26 / 36 | 15 / 35 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 | 0 / 12 | 0 / 35 | 1 / 36 | 2 / 36 | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 35 |
Outcome results
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
Time frame: Stage I: Baseline, Day 14
Population: ITT population included all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Baseline | 25.97 mmHg | Standard Deviation 2.42 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Change at Day 14 | 3.65 mmHg | Standard Deviation 1.749 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Change at Day 14 | 5.40 mmHg | Standard Deviation 2.508 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Baseline | 26.25 mmHg | Standard Deviation 2.4 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Baseline | 25.90 mmHg | Standard Deviation 2.094 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Change at Day 14 | 7.18 mmHg | Standard Deviation 2.749 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Change at Day 14 | 6.48 mmHg | Standard Deviation 4.278 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Baseline | 26.44 mmHg | Standard Deviation 1.56 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Baseline | 28.10 mmHg | Standard Deviation 3.102 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Change at Day 14 | 6.00 mmHg | Standard Deviation 2.748 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Baseline | 26.26 mmHg | Standard Deviation 1.831 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Change at Day 14 | 6.69 mmHg | Standard Deviation 4.563 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Baseline | 26.04 mmHg | Standard Deviation 2.182 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I | Change at Day 14 | 0.64 mmHg | Standard Deviation 1.382 |
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
Time frame: Stage II: Baseline, Day 28
Population: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Baseline | 25.75 mmHg | Standard Deviation 2.266 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Change at Day 28 | 7.35 mmHg | Standard Deviation 3.559 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Baseline | 26.47 mmHg | Standard Deviation 2.563 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Change at Day 28 | 7.05 mmHg | Standard Deviation 2.875 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Baseline | 26.69 mmHg | Standard Deviation 2.509 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Change at Day 28 | 7.14 mmHg | Standard Deviation 3.462 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Baseline | 26.98 mmHg | Standard Deviation 2.813 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Change at Day 28 | 8.29 mmHg | Standard Deviation 3.817 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Baseline | 26.36 mmHg | Standard Deviation 2.524 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Change at Day 28 | 9.10 mmHg | Standard Deviation 3.292 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Baseline | 27.34 mmHg | Standard Deviation 2.876 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Change at Day 28 | 8.78 mmHg | Standard Deviation 3.592 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Baseline | 26.81 mmHg | Standard Deviation 2.783 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II | Change at Day 28 | 6.74 mmHg | Standard Deviation 2.927 |
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Time frame: Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Taprenepag 0.0025% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | 1 Participants |
| Taprenepag 0.005% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | 2 Participants |
| Taprenepag 0.01% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | 0 Participants |
| Taprenepag 0.015% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | 5 Participants |
| Taprenepag 0.02% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | 4 Participants |
| Taprenepag 0.03% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | 9 Participants |
| Taprenepag Vehicle (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I | 3 Participants |
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Time frame: Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
Population: ITT population included all randomized participants who received at least 1 dose of study medication.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Taprenepag 0.0025% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | 17 Participants |
| Taprenepag 0.005% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | 20 Participants |
| Taprenepag 0.01% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | 27 Participants |
| Taprenepag 0.015% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | 24 Participants |
| Taprenepag 0.02% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | 26 Participants |
| Taprenepag 0.03% (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | 26 Participants |
| Taprenepag Vehicle (Stage I) | Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II | 14 Participants |
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
Time frame: Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Population: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 1PM | 24.84 mmHg | Standard Deviation 2.466 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7,14,28: 8AM | 27.59 mmHg | Standard Deviation 2.098 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 10AM | 25.74 mmHg | Standard Deviation 3.129 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 1PM | 24.85 mmHg | Standard Deviation 2.501 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 4PM | 24.83 mmHg | Standard Deviation 2.901 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 10AM | 25.70 mmHg | Standard Deviation 3.089 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 1: 8AM | 27.34 mmHg | Standard Deviation 1.525 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 4PM | 24.87 mmHg | Standard Deviation 2.868 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 10AM | 25.70 mmHg | Standard Deviation 3.089 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 1PM | 24.84 mmHg | Standard Deviation 2.466 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 4PM | 24.87 mmHg | Standard Deviation 2.868 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 1: 8AM | 8.22 mmHg | Standard Deviation 4.071 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 8AM | 9.24 mmHg | Standard Deviation 3.987 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 10AM | 8.47 mmHg | Standard Deviation 3.754 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 1PM | 7.60 mmHg | Standard Deviation 3.499 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 4PM | 7.57 mmHg | Standard Deviation 3.525 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 8AM | 8.74 mmHg | Standard Deviation 3.829 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 10AM | 7.89 mmHg | Standard Deviation 4.568 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 1PM | 6.89 mmHg | Standard Deviation 4.225 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 4PM | 7.46 mmHg | Standard Deviation 3.725 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 8AM | 7.99 mmHg | Standard Deviation 4.108 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 10AM | 7.78 mmHg | Standard Deviation 3.987 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 1PM | 6.54 mmHg | Standard Deviation 3.965 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 4PM | 7.09 mmHg | Standard Deviation 3.938 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 10AM | 26.44 mmHg | Standard Deviation 3.005 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 10AM | 26.44 mmHg | Standard Deviation 3.005 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 10AM | 7.49 mmHg | Standard Deviation 3.057 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 8AM | 8.76 mmHg | Standard Deviation 3.459 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 1PM | 6.47 mmHg | Standard Deviation 2.645 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 1: 8AM | 6.29 mmHg | Standard Deviation 3.117 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7,14,28: 8AM | 28.16 mmHg | Standard Deviation 2.333 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 1PM | 25.67 mmHg | Standard Deviation 2.754 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 1: 8AM | 28.21 mmHg | Standard Deviation 2.349 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 1PM | 25.67 mmHg | Standard Deviation 2.754 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 10AM | 7.00 mmHg | Standard Deviation 3.383 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 8AM | 8.40 mmHg | Standard Deviation 3.501 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 4PM | 6.24 mmHg | Standard Deviation 3.51 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 4PM | 25.59 mmHg | Standard Deviation 3.04 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 4PM | 25.59 mmHg | Standard Deviation 3.04 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 1PM | 6.33 mmHg | Standard Deviation 2.837 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 4PM | 6.51 mmHg | Standard Deviation 3.302 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 10AM | 26.44 mmHg | Standard Deviation 3.005 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 10AM | 6.83 mmHg | Standard Deviation 3.151 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 8AM | 8.60 mmHg | Standard Deviation 3.254 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 1PM | 25.67 mmHg | Standard Deviation 2.754 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 4PM | 6.92 mmHg | Standard Deviation 3.552 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 1PM | 6.99 mmHg | Standard Deviation 2.943 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 4PM | 25.59 mmHg | Standard Deviation 3.04 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 1PM | 26.19 mmHg | Standard Deviation 2.992 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 4PM | 6.74 mmHg | Standard Deviation 4.48 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 8AM | 8.55 mmHg | Standard Deviation 3.473 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 8AM | 8.59 mmHg | Standard Deviation 3.317 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 4PM | 25.86 mmHg | Standard Deviation 3.013 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 10AM | 8.10 mmHg | Standard Deviation 3.328 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 1PM | 7.17 mmHg | Standard Deviation 3.502 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 1: 8AM | 7.66 mmHg | Standard Deviation 3.11 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7,14,28: 8AM | 28.27 mmHg | Standard Deviation 2.155 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 1PM | 7.07 mmHg | Standard Deviation 3.472 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 4PM | 7.60 mmHg | Standard Deviation 3.388 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 10AM | 6.92 mmHg | Standard Deviation 3.706 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 4PM | 25.86 mmHg | Standard Deviation 3.013 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 10AM | 26.66 mmHg | Standard Deviation 2.854 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 1PM | 7.46 mmHg | Standard Deviation 3.576 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 1: 8AM | 28.27 mmHg | Standard Deviation 2.155 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 10AM | 7.22 mmHg | Standard Deviation 3.292 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 8AM | 8.00 mmHg | Standard Deviation 3.851 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 10AM | 26.70 mmHg | Standard Deviation 2.937 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 1PM | 26.13 mmHg | Standard Deviation 2.949 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 1PM | 26.13 mmHg | Standard Deviation 2.949 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 10AM | 26.66 mmHg | Standard Deviation 2.854 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 4PM | 25.87 mmHg | Standard Deviation 3.054 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 4PM | 7.55 mmHg | Standard Deviation 3.392 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 1PM | 26.04 mmHg | Standard Deviation 3.179 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 4PM | 25.92 mmHg | Standard Deviation 3.293 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 10AM | 26.94 mmHg | Standard Deviation 3.449 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 10AM | 8.68 mmHg | Standard Deviation 4.674 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 1PM | 25.92 mmHg | Standard Deviation 3.068 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 4PM | 25.99 mmHg | Standard Deviation 3.206 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 10AM | 27.06 mmHg | Standard Deviation 3.467 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 1PM | 25.98 mmHg | Standard Deviation 3.042 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 4PM | 26.00 mmHg | Standard Deviation 3.156 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 1: 8AM | 9.72 mmHg | Standard Deviation 3.484 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 8AM | 10.20 mmHg | Standard Deviation 3.497 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 1PM | 7.51 mmHg | Standard Deviation 3.915 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 10AM | 9.19 mmHg | Standard Deviation 3.646 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 1PM | 8.02 mmHg | Standard Deviation 4.046 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 4PM | 8.27 mmHg | Standard Deviation 3.161 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 8AM | 9.50 mmHg | Standard Deviation 3.915 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 10AM | 7.95 mmHg | Standard Deviation 3.9 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 1PM | 7.03 mmHg | Standard Deviation 3.71 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 4PM | 7.33 mmHg | Standard Deviation 3.649 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 4PM | 6.94 mmHg | Standard Deviation 3.962 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 8AM | 9.92 mmHg | Standard Deviation 3.845 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 1: 8AM | 29.10 mmHg | Standard Deviation 2.714 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7,14,28: 8AM | 29.03 mmHg | Standard Deviation 2.71 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 10AM | 27.13 mmHg | Standard Deviation 3.453 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 10AM | 26.42 mmHg | Standard Deviation 2.779 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 1PM | 8.66 mmHg | Standard Deviation 4.073 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 10AM | 26.42 mmHg | Standard Deviation 2.779 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 10AM | 9.76 mmHg | Standard Deviation 3.467 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 8AM | 11.22 mmHg | Standard Deviation 3.393 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 10AM | 9.55 mmHg | Standard Deviation 3.561 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 1PM | 8.83 mmHg | Standard Deviation 3.364 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 4PM | 25.35 mmHg | Standard Deviation 3.117 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 4PM | 25.35 mmHg | Standard Deviation 3.117 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 1PM | 25.34 mmHg | Standard Deviation 2.707 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 1PM | 25.34 mmHg | Standard Deviation 2.707 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 1: 8AM | 9.87 mmHg | Standard Deviation 2.786 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 1: 8AM | 28.63 mmHg | Standard Deviation 2.648 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 4PM | 8.44 mmHg | Standard Deviation 2.888 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 10AM | 9.61 mmHg | Standard Deviation 3.448 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 4PM | 8.23 mmHg | Standard Deviation 3.42 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 10AM | 26.42 mmHg | Standard Deviation 2.779 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 8AM | 10.66 mmHg | Standard Deviation 3.741 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7,14,28: 8AM | 28.63 mmHg | Standard Deviation 2.648 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 4PM | 25.35 mmHg | Standard Deviation 3.117 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 8AM | 10.94 mmHg | Standard Deviation 3.793 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 1PM | 8.54 mmHg | Standard Deviation 3.043 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 1PM | 25.34 mmHg | Standard Deviation 2.707 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 4PM | 8.36 mmHg | Standard Deviation 3.721 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 4PM | 26.20 mmHg | Standard Deviation 3.145 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 1PM | 26.21 mmHg | Standard Deviation 3.297 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 1PM | 9.17 mmHg | Standard Deviation 4.022 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 1PM | 8.82 mmHg | Standard Deviation 4.037 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 4PM | 8.55 mmHg | Standard Deviation 3.081 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 10AM | 27.41 mmHg | Standard Deviation 3.423 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 8AM | 10.52 mmHg | Standard Deviation 4.446 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 10AM | 9.74 mmHg | Standard Deviation 3.743 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 10AM | 9.56 mmHg | Standard Deviation 3.121 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 4PM | 26.20 mmHg | Standard Deviation 3.145 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 1PM | 8.86 mmHg | Standard Deviation 3.71 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 1PM | 26.21 mmHg | Standard Deviation 3.297 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 4PM | 7.95 mmHg | Standard Deviation 3.045 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 10AM | 27.48 mmHg | Standard Deviation 3.45 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 10AM | 27.41 mmHg | Standard Deviation 3.423 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 1: 8AM | 29.19 mmHg | Standard Deviation 2.962 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 8AM | 10.20 mmHg | Standard Deviation 3.958 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 4PM | 26.12 mmHg | Standard Deviation 3.154 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 1: 8AM | 9.49 mmHg | Standard Deviation 4.242 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 10AM | 10.14 mmHg | Standard Deviation 2.935 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 1PM | 26.27 mmHg | Standard Deviation 3.335 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 8AM | 10.91 mmHg | Standard Deviation 3.623 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 4PM | 7.64 mmHg | Standard Deviation 3.762 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7,14,28: 8AM | 29.19 mmHg | Standard Deviation 2.962 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 10AM | 26.70 mmHg | Standard Deviation 3.25 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7,14,28: 8AM | 28.60 mmHg | Standard Deviation 2.656 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 1PM | 6.66 mmHg | Standard Deviation 2.804 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 4PM | 6.14 mmHg | Standard Deviation 3.011 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 8AM | 7.91 mmHg | Standard Deviation 2.802 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 1PM | 25.99 mmHg | Standard Deviation 2.863 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 1: 8AM | 28.55 mmHg | Standard Deviation 2.728 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 1PM | 6.69 mmHg | Standard Deviation 2.996 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 4PM | 25.84 mmHg | Standard Deviation 3.243 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 10AM | 7.60 mmHg | Standard Deviation 3.031 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 4PM | 25.84 mmHg | Standard Deviation 3.243 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 7: 8AM | 8.50 mmHg | Standard Deviation 3.343 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 1PM | 7.16 mmHg | Standard Deviation 3.229 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 10AM | 7.30 mmHg | Standard Deviation 2.397 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 1PM | 25.99 mmHg | Standard Deviation 2.863 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 1: 8AM | 8.16 mmHg | Standard Deviation 4.031 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 1PM | 25.99 mmHg | Standard Deviation 2.863 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 4PM | 5.79 mmHg | Standard Deviation 3.219 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 28: 10AM | 7.06 mmHg | Standard Deviation 3.311 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 4PM | 6.30 mmHg | Standard Deviation 3.746 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 28: 4PM | 25.84 mmHg | Standard Deviation 3.243 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Change at Day 14: 8AM | 8.94 mmHg | Standard Deviation 3.462 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 14: 10AM | 26.70 mmHg | Standard Deviation 3.25 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II | Day 0: Baseline for Day 7: 10AM | 26.70 mmHg | Standard Deviation 3.25 |
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
Time frame: Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
Population: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 1 PM | 25.83 mmHg | Standard Deviation 3.279 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 10 AM | 24.75 mmHg | Standard Deviation 1.916 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 4 PM | 25.50 mmHg | Standard Deviation 3.403 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 1 PM | 4.56 mmHg | Standard Deviation 2.524 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 10 AM | 3.86 mmHg | Standard Deviation 1.768 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 8 AM | 3.44 mmHg | Standard Deviation 3.964 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 10 AM | 24.75 mmHg | Standard Deviation 1.916 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day0: Baseline for Day 1, 7, 14 8 AM | 27.78 mmHg | Standard Deviation 1.847 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 4 PM | 4.33 mmHg | Standard Deviation 2.88 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 1 PM | 4.67 mmHg | Standard Deviation 3.255 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 10 AM | 3.58 mmHg | Standard Deviation 3.064 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 8 AM | 4.56 mmHg | Standard Deviation 2.957 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 1 8 AM | 4.89 mmHg | Standard Deviation 2.302 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 1 PM | 25.83 mmHg | Standard Deviation 3.279 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 4 PM | 2.72 mmHg | Standard Deviation 1.95 |
| Taprenepag 0.0025% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 4 PM | 25.50 mmHg | Standard Deviation 3.403 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 1 PM | 6.22 mmHg | Standard Deviation 2.498 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 10 AM | 26.11 mmHg | Standard Deviation 2.494 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 1 PM | 26.06 mmHg | Standard Deviation 2.965 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 4 PM | 25.11 mmHg | Standard Deviation 3.113 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 10 AM | 26.11 mmHg | Standard Deviation 2.494 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 1 PM | 26.06 mmHg | Standard Deviation 2.965 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 4 PM | 25.11 mmHg | Standard Deviation 3.113 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 1 8 AM | 5.44 mmHg | Standard Deviation 3.154 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 8 AM | 6.67 mmHg | Standard Deviation 1.644 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 10 AM | 7.00 mmHg | Standard Deviation 3.219 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day0: Baseline for Day 1, 7, 14 8 AM | 27.72 mmHg | Standard Deviation 1.693 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 4 PM | 5.06 mmHg | Standard Deviation 4.083 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 8 AM | 6.11 mmHg | Standard Deviation 3.518 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 10 AM | 6.33 mmHg | Standard Deviation 2.559 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 1 PM | 5.22 mmHg | Standard Deviation 2.673 |
| Taprenepag 0.005% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 4 PM | 3.94 mmHg | Standard Deviation 2.88 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 10 AM | 7.56 mmHg | Standard Deviation 3.041 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 10 AM | 25.94 mmHg | Standard Deviation 2.872 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 10 AM | 25.94 mmHg | Standard Deviation 2.872 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 4 PM | 6.08 mmHg | Standard Deviation 3.573 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 1 PM | 7.86 mmHg | Standard Deviation 2.908 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 1 PM | 25.08 mmHg | Standard Deviation 2.208 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 4 PM | 24.86 mmHg | Standard Deviation 2.405 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 4 PM | 24.86 mmHg | Standard Deviation 2.405 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 1 PM | 6.53 mmHg | Standard Deviation 2.746 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 10 AM | 7.67 mmHg | Standard Deviation 3.245 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 1 8 AM | 7.72 mmHg | Standard Deviation 2.697 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 1 PM | 25.08 mmHg | Standard Deviation 2.208 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 8 AM | 8.44 mmHg | Standard Deviation 2.267 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 8 AM | 8.28 mmHg | Standard Deviation 4.186 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 4 PM | 7.25 mmHg | Standard Deviation 2.929 |
| Taprenepag 0.01% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day0: Baseline for Day 1, 7, 14 8 AM | 27.72 mmHg | Standard Deviation 2.403 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 10 AM | 6.40 mmHg | Standard Deviation 4.754 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 10 AM | 7.15 mmHg | Standard Deviation 4.301 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 4 PM | 6.30 mmHg | Standard Deviation 5.296 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 8 AM | 8.20 mmHg | Standard Deviation 3.885 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 1 PM | 7.55 mmHg | Standard Deviation 3.947 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 10 AM | 26.30 mmHg | Standard Deviation 1.285 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 1 8 AM | 6.75 mmHg | Standard Deviation 2.875 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 1 PM | 25.10 mmHg | Standard Deviation 2.289 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 1 PM | 5.50 mmHg | Standard Deviation 4.419 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 8 AM | 7.70 mmHg | Standard Deviation 3.994 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 4 PM | 25.90 mmHg | Standard Deviation 2.237 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 1 PM | 25.10 mmHg | Standard Deviation 2.289 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 4 PM | 25.90 mmHg | Standard Deviation 2.237 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 10 AM | 26.30 mmHg | Standard Deviation 1.285 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 4 PM | 8.95 mmHg | Standard Deviation 3.787 |
| Taprenepag 0.015% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day0: Baseline for Day 1, 7, 14 8 AM | 28.45 mmHg | Standard Deviation 1.471 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 10 AM | 27.44 mmHg | Standard Deviation 3.269 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 1 PM | 5.14 mmHg | Standard Deviation 3.664 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 1 PM | 28.03 mmHg | Standard Deviation 3.906 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 4 PM | 27.11 mmHg | Standard Deviation 3.564 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 1 8 AM | 7.75 mmHg | Standard Deviation 3.276 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 8 AM | 9.58 mmHg | Standard Deviation 3.356 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 10 AM | 26.53 mmHg | Standard Deviation 1.906 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 10 AM | 6.16 mmHg | Standard Deviation 2.891 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 1 PM | 6.50 mmHg | Standard Deviation 4.652 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 4 PM | 5.53 mmHg | Standard Deviation 4.519 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 4 PM | 6.44 mmHg | Standard Deviation 3.015 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 8 AM | 6.86 mmHg | Standard Deviation 2.622 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 10 AM | 5.56 mmHg | Standard Deviation 3.273 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day0: Baseline for Day 1, 7, 14 8 AM | 29.81 mmHg | Standard Deviation 2.769 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 4 PM | 26.41 mmHg | Standard Deviation 3.068 |
| Taprenepag 0.02% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 1 PM | 27.13 mmHg | Standard Deviation 3.009 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 4 PM | 25.28 mmHg | Standard Deviation 1.925 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 4 PM | 6.66 mmHg | Standard Deviation 3.744 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 1 8 AM | 7.22 mmHg | Standard Deviation 4.459 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 10 AM | 26.16 mmHg | Standard Deviation 2.507 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 8 AM | 8.28 mmHg | Standard Deviation 5.701 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day0: Baseline for Day 1, 7, 14 8 AM | 28.44 mmHg | Standard Deviation 1.887 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 4 PM | 6.22 mmHg | Standard Deviation 4.021 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 10 AM | 8.09 mmHg | Standard Deviation 4.274 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 1 PM | 25.69 mmHg | Standard Deviation 2.191 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 1 PM | 25.69 mmHg | Standard Deviation 2.191 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 4 PM | 25.28 mmHg | Standard Deviation 1.925 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 1 PM | 7.19 mmHg | Standard Deviation 2.93 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 1 PM | 7.44 mmHg | Standard Deviation 3.351 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 10 AM | 8.72 mmHg | Standard Deviation 4.137 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 8 AM | 7.67 mmHg | Standard Deviation 4.373 |
| Taprenepag 0.03% (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 10 AM | 26.16 mmHg | Standard Deviation 2.507 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 10 AM | 0.67 mmHg | Standard Deviation 3.085 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 10 AM | -0.33 mmHg | Standard Deviation 3.099 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 4 PM | -0.23 mmHg | Standard Deviation 2.94 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day0: Baseline for Day 1, 7, 14 8 AM | 28.15 mmHg | Standard Deviation 2.625 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 4 PM | 25.35 mmHg | Standard Deviation 2.907 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 1 8 AM | 1.35 mmHg | Standard Deviation 2.702 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 4 PM | 0.27 mmHg | Standard Deviation 1.804 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 1 PM | 25.52 mmHg | Standard Deviation 2.742 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 10 AM | 25.13 mmHg | Standard Deviation 2.519 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 8 AM | 1.56 mmHg | Standard Deviation 2.962 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 4 PM | 25.35 mmHg | Standard Deviation 2.907 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 8 AM | 2.15 mmHg | Standard Deviation 3.224 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 14 1 PM | 0.06 mmHg | Standard Deviation 2.794 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0: Baseline for Day 7 10 AM | 25.13 mmHg | Standard Deviation 2.519 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Day 0:Baseline for Day 14 1 PM | 25.52 mmHg | Standard Deviation 2.742 |
| Taprenepag Vehicle (Stage I) | Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I | Change at Day 7 1 PM | 1.90 mmHg | Standard Deviation 2.546 |
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Time frame: Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Population: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 1 PM | 21.17 mmHg | Standard Deviation 2.525 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 10 AM | 20.89 mmHg | Standard Deviation 1.635 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 10 AM | 21.17 mmHg | Standard Deviation 2.165 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 4 PM | 21.17 mmHg | Standard Deviation 3.491 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 1 PM | 21.28 mmHg | Standard Deviation 2.078 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 8 AM | 24.33 mmHg | Standard Deviation 4.737 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 4 PM | 22.78 mmHg | Standard Deviation 3.914 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 8 AM | 23.22 mmHg | Standard Deviation 3.563 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 1: 8 AM | 22.89 mmHg | Standard Deviation 3.14 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 8 AM | 21.61 mmHg | Standard Deviation 3.927 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 4 PM | 20.06 mmHg | Standard Deviation 5.282 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 4 PM | 21.17 mmHg | Standard Deviation 3.841 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 8 AM | 21.06 mmHg | Standard Deviation 2.888 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 1 PM | 20.83 mmHg | Standard Deviation 2.839 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 10 AM | 19.11 mmHg | Standard Deviation 3.943 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 1: 8 AM | 22.28 mmHg | Standard Deviation 3.709 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 10 AM | 19.78 mmHg | Standard Deviation 2.74 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 1 PM | 19.83 mmHg | Standard Deviation 3.269 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 10 AM | 18.28 mmHg | Standard Deviation 3.501 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 4 PM | 17.61 mmHg | Standard Deviation 3.935 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 1: 8 AM | 20.00 mmHg | Standard Deviation 1.677 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 8 AM | 19.44 mmHg | Standard Deviation 4.081 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 8 AM | 19.28 mmHg | Standard Deviation 2.438 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 1 PM | 18.56 mmHg | Standard Deviation 3.754 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 1 PM | 17.22 mmHg | Standard Deviation 4.063 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 10 AM | 18.39 mmHg | Standard Deviation 3.11 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 4 PM | 18.78 mmHg | Standard Deviation 3.97 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 8 AM | 20.75 mmHg | Standard Deviation 4.906 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 1: 8 AM | 21.70 mmHg | Standard Deviation 3.425 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 8 AM | 20.25 mmHg | Standard Deviation 4.584 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 10 AM | 19.15 mmHg | Standard Deviation 4.429 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 1 PM | 17.55 mmHg | Standard Deviation 3.905 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 4 PM | 16.95 mmHg | Standard Deviation 3.954 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 10 AM | 19.90 mmHg | Standard Deviation 4.858 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 1 PM | 19.60 mmHg | Standard Deviation 5.254 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 4 PM | 19.60 mmHg | Standard Deviation 5.004 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 10 AM | 20.38 mmHg | Standard Deviation 2.888 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 1: 8 AM | 22.06 mmHg | Standard Deviation 2.732 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 10 AM | 21.89 mmHg | Standard Deviation 3.798 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 1 PM | 22.89 mmHg | Standard Deviation 4.029 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 1 PM | 20.63 mmHg | Standard Deviation 4.224 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 8 AM | 22.94 mmHg | Standard Deviation 3.787 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 8 AM | 20.22 mmHg | Standard Deviation 3.866 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 4 PM | 20.67 mmHg | Standard Deviation 2.704 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 4 PM | 20.88 mmHg | Standard Deviation 4.604 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 4 PM | 19.06 mmHg | Standard Deviation 3.886 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 1 PM | 18.50 mmHg | Standard Deviation 3.703 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 1: 8 AM | 21.22 mmHg | Standard Deviation 4.214 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 4 PM | 18.63 mmHg | Standard Deviation 3.926 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 10 AM | 17.44 mmHg | Standard Deviation 3.803 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 10 AM | 18.06 mmHg | Standard Deviation 4.724 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 1 PM | 18.25 mmHg | Standard Deviation 4.359 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 8 AM | 20.78 mmHg | Standard Deviation 3.42 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 8 AM | 20.17 mmHg | Standard Deviation 5.75 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 8 AM | 26.00 mmHg | Standard Deviation 4.843 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 10 AM | 24.46 mmHg | Standard Deviation 2.463 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 8 AM | 26.58 mmHg | Standard Deviation 4.592 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 10 AM | 25.46 mmHg | Standard Deviation 4.293 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 1 PM | 23.63 mmHg | Standard Deviation 2.909 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 4 PM | 25.08 mmHg | Standard Deviation 3.154 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 14: 1 PM | 25.46 mmHg | Standard Deviation 3.665 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 1: 8 AM | 26.79 mmHg | Standard Deviation 4.335 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I | Day 7: 4 PM | 25.58 mmHg | Standard Deviation 5.044 |
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Time frame: Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Population: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 8 AM | 18.34 mmHg | Standard Deviation 3.115 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 10 AM | 17.26 mmHg | Standard Deviation 2.456 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 4 PM | 17.79 mmHg | Standard Deviation 3.673 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 1: 8 AM | 19.12 mmHg | Standard Deviation 3.514 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 8 AM | 19.60 mmHg | Standard Deviation 3.794 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 8 AM | 18.85 mmHg | Standard Deviation 3.439 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 4 PM | 17.41 mmHg | Standard Deviation 3.452 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 1 PM | 18.30 mmHg | Standard Deviation 3.787 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 1 PM | 17.25 mmHg | Standard Deviation 3.184 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 4 PM | 17.26 mmHg | Standard Deviation 2.962 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 10 AM | 17.93 mmHg | Standard Deviation 3.341 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 1 PM | 17.94 mmHg | Standard Deviation 3.912 |
| Taprenepag 0.0025% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 10 AM | 17.81 mmHg | Standard Deviation 3.848 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 10 AM | 19.61 mmHg | Standard Deviation 4.209 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 8 AM | 19.56 mmHg | Standard Deviation 3.288 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 4 PM | 18.67 mmHg | Standard Deviation 3.69 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 1 PM | 19.19 mmHg | Standard Deviation 3.092 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 8 AM | 19.40 mmHg | Standard Deviation 3.308 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 1: 8 AM | 21.91 mmHg | Standard Deviation 3.177 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 10 AM | 19.44 mmHg | Standard Deviation 3.335 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 8 AM | 19.76 mmHg | Standard Deviation 3.188 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 10 AM | 18.96 mmHg | Standard Deviation 3.938 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 4 PM | 19.35 mmHg | Standard Deviation 4.035 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 1 PM | 19.33 mmHg | Standard Deviation 3.619 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 1 PM | 18.68 mmHg | Standard Deviation 3.122 |
| Taprenepag 0.005% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 4 PM | 19.08 mmHg | Standard Deviation 3.394 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 4 PM | 19.13 mmHg | Standard Deviation 4.396 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 1: 8 AM | 20.61 mmHg | Standard Deviation 2.859 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 8 AM | 19.68 mmHg | Standard Deviation 3.14 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 10 AM | 18.61 mmHg | Standard Deviation 2.814 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 1 PM | 18.73 mmHg | Standard Deviation 3.518 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 4 PM | 18.27 mmHg | Standard Deviation 3.047 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 8 AM | 19.72 mmHg | Standard Deviation 3.644 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 10 AM | 19.44 mmHg | Standard Deviation 3.318 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 1 PM | 18.96 mmHg | Standard Deviation 3.776 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 4 PM | 18.31 mmHg | Standard Deviation 3.37 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 8 AM | 20.28 mmHg | Standard Deviation 4.294 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 10 AM | 19.74 mmHg | Standard Deviation 3.764 |
| Taprenepag 0.01% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 1 PM | 19.06 mmHg | Standard Deviation 3.399 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 1 PM | 18.89 mmHg | Standard Deviation 3.219 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 8 AM | 19.53 mmHg | Standard Deviation 3.572 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 8 AM | 19.11 mmHg | Standard Deviation 3.28 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 10 AM | 17.94 mmHg | Standard Deviation 2.551 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 4 PM | 18.66 mmHg | Standard Deviation 3.117 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 4 PM | 17.65 mmHg | Standard Deviation 2.998 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 10 AM | 18.98 mmHg | Standard Deviation 3.318 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 1 PM | 18.47 mmHg | Standard Deviation 2.396 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 1: 8 AM | 19.39 mmHg | Standard Deviation 3.229 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 8 AM | 18.83 mmHg | Standard Deviation 2.908 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 1 PM | 18.02 mmHg | Standard Deviation 2.872 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 10 AM | 18.38 mmHg | Standard Deviation 3.038 |
| Taprenepag 0.015% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 4 PM | 19.06 mmHg | Standard Deviation 2.772 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 4 PM | 16.91 mmHg | Standard Deviation 4.32 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 1 PM | 16.80 mmHg | Standard Deviation 4.219 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 1: 8 AM | 18.76 mmHg | Standard Deviation 4.058 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 10 AM | 16.66 mmHg | Standard Deviation 4.743 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 1 PM | 16.52 mmHg | Standard Deviation 4.622 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 10 AM | 16.80 mmHg | Standard Deviation 4.67 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 4 PM | 17.12 mmHg | Standard Deviation 4.823 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 4 PM | 16.98 mmHg | Standard Deviation 5.077 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 8 AM | 17.97 mmHg | Standard Deviation 4.876 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 8 AM | 17.41 mmHg | Standard Deviation 4.035 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 10 AM | 16.86 mmHg | Standard Deviation 4.827 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 1 PM | 16.68 mmHg | Standard Deviation 5.331 |
| Taprenepag 0.02% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 8 AM | 17.69 mmHg | Standard Deviation 4.58 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 8 AM | 18.99 mmHg | Standard Deviation 3.644 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 10 AM | 17.85 mmHg | Standard Deviation 3.282 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 1 PM | 17.09 mmHg | Standard Deviation 3.057 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 1: 8 AM | 19.69 mmHg | Standard Deviation 3.945 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 1 PM | 17.39 mmHg | Standard Deviation 2.68 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 10 AM | 17.67 mmHg | Standard Deviation 3.196 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 8 AM | 18.67 mmHg | Standard Deviation 4.127 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 10 AM | 17.34 mmHg | Standard Deviation 3.028 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 4 PM | 17.56 mmHg | Standard Deviation 2.989 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 4 PM | 18.26 mmHg | Standard Deviation 2.736 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 1 PM | 17.35 mmHg | Standard Deviation 2.612 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 8 AM | 18.28 mmHg | Standard Deviation 3.718 |
| Taprenepag 0.03% (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 4 PM | 18.56 mmHg | Standard Deviation 3.323 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 8 AM | 20.10 mmHg | Standard Deviation 3.698 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 4 PM | 19.70 mmHg | Standard Deviation 3.642 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 8 AM | 20.69 mmHg | Standard Deviation 3.577 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 8 AM | 19.66 mmHg | Standard Deviation 3.908 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 4 PM | 20.06 mmHg | Standard Deviation 3.668 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 10 AM | 19.10 mmHg | Standard Deviation 3.727 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 7: 1 PM | 19.30 mmHg | Standard Deviation 3.032 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 10 AM | 19.64 mmHg | Standard Deviation 3.966 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 10 AM | 19.40 mmHg | Standard Deviation 3.485 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 1: 8 AM | 20.39 mmHg | Standard Deviation 3.548 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 28: 1 PM | 19.33 mmHg | Standard Deviation 3.204 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 4 PM | 19.54 mmHg | Standard Deviation 3.361 |
| Taprenepag Vehicle (Stage I) | Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II | Day 14: 1 PM | 18.83 mmHg | Standard Deviation 3.231 |
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Percentage of participants who reached an IOP of less than or equal to (\<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
Time frame: Stage I: Day 1 up to Day 14
Population: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Taprenepag 0.0025% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | 0.0 percentage of participants |
| Taprenepag 0.005% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | 11.1 percentage of participants |
| Taprenepag 0.01% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | 11.1 percentage of participants |
| Taprenepag 0.015% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | 0.0 percentage of participants |
| Taprenepag 0.02% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | 11.1 percentage of participants |
| Taprenepag 0.03% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | 22.2 percentage of participants |
| Taprenepag Vehicle (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I | 0.0 percentage of participants |
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Percentage of participants who reached an IOP \<= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.
Time frame: Stage II: Day 1 up to Day 28
Population: ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Taprenepag 0.0025% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | 22.9 percentage of participants |
| Taprenepag 0.005% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | 2.8 percentage of participants |
| Taprenepag 0.01% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | 13.9 percentage of participants |
| Taprenepag 0.015% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | 8.3 percentage of participants |
| Taprenepag 0.02% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | 38.9 percentage of participants |
| Taprenepag 0.03% (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | 16.7 percentage of participants |
| Taprenepag Vehicle (Stage I) | Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II | 5.7 percentage of participants |