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Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.

A 2-STAGE, PHASE 2, DOUBLE-MASKED, RANDOMIZED, VEHICLE CONTROLLED, DOSE RESPONSE TRIAL OF PF-04217329 AND THE MARKETED FORMULATION OF LATANOPROST IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00572455
Enrollment
318
Registered
2007-12-13
Start date
2007-12-11
Completion date
2009-06-26
Last updated
2021-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Open-Angle Glaucoma, Ocular Hypertension

Keywords

Open-Angle Glaucoma, Ocular Hypertension

Brief summary

To evaluate the safety and efficacy of PF-04217329.

Interventions

DRUGPF-04217329 - Lowest Dose

1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.

DRUGPF-04217329 - Low Dose

1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.

DRUGPF-04217329 - Middle Dose

1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.

DRUGPF-04217329 - High Middle Dose

1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.

DRUGPF-04217329 - High Dose

1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.

DRUGPF-4217329 - Highest Dose

1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.

DRUGPF-04217329 - Vehicle

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

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage IStage I: Baseline, Day 14Diurnal 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 IIStage II: Baseline, Day 28Diurnal 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 IStage 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 IIStage 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

MeasureTime frameDescription
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IStage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14IOP 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 IStage 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 14IOP 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 IIStage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28IOP 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 IIStage 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 28IOP 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 IStage I: Day 1 up to Day 14Percentage 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 IIStage II: Day 1 up to Day 28Percentage 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

ArmCount
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
Total317

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007FG008FG009FG010FG011FG012FG013
Stage I (14 Days)Adverse Event00000300000000
Stage I (14 Days)Other00001000000000
Stage II (28 Days)Adverse Event00000000133451
Stage II (28 Days)Death00000000100000
Stage II (28 Days)Other00000000100000
Stage II (28 Days)Randomized, but not treated00000000000001
Stage II (28 Days)Withdrawal by Subject00000001002000

Baseline characteristics

CharacteristicTaprenepag 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, Continuous59.1 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 Participants7 Participants6 Participants10 Participants3 Participants6 Participants8 Participants25 Participants22 Participants21 Participants24 Participants25 Participants21 Participants22 Participants204 Participants
Sex: Female, Male
Male
5 Participants2 Participants3 Participants0 Participants6 Participants3 Participants4 Participants10 Participants14 Participants15 Participants12 Participants11 Participants15 Participants13 Participants113 Participants

Adverse events

Event typeEG000
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 / 93 / 90 / 95 / 105 / 99 / 94 / 1218 / 3520 / 3627 / 3624 / 3627 / 3626 / 3615 / 35
serious
Total, serious adverse events
0 / 90 / 90 / 90 / 100 / 90 / 90 / 120 / 351 / 362 / 360 / 360 / 360 / 360 / 35

Outcome results

Primary

Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I

Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.

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.

ArmMeasureGroupValue (MEAN)Dispersion
Taprenepag 0.0025% (Stage I)Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage IBaseline25.97 mmHgStandard 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 IChange at Day 143.65 mmHgStandard 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 IChange at Day 145.40 mmHgStandard 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 IBaseline26.25 mmHgStandard 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 IBaseline25.90 mmHgStandard 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 IChange at Day 147.18 mmHgStandard 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 IChange at Day 146.48 mmHgStandard 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 IBaseline26.44 mmHgStandard 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 IBaseline28.10 mmHgStandard 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 IChange at Day 146.00 mmHgStandard 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 IBaseline26.26 mmHgStandard 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 IChange at Day 146.69 mmHgStandard Deviation 4.563
Taprenepag Vehicle (Stage I)Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage IBaseline26.04 mmHgStandard Deviation 2.182
Taprenepag Vehicle (Stage I)Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage IChange at Day 140.64 mmHgStandard Deviation 1.382
Comparison: Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.02890% CI: [0.78, 5.25]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [2.5, 6.96]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.33, 8.79]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.6, 7.95]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [2.74, 7.37]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.79, 8.25]ANCOVA
Primary

Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II

Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.

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.

ArmMeasureGroupValue (MEAN)Dispersion
Taprenepag 0.0025% (Stage I)Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage IIBaseline25.75 mmHgStandard 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 IIChange at Day 287.35 mmHgStandard 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 IIBaseline26.47 mmHgStandard 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 IIChange at Day 287.05 mmHgStandard 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 IIBaseline26.69 mmHgStandard 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 IIChange at Day 287.14 mmHgStandard 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 IIBaseline26.98 mmHgStandard 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 IIChange at Day 288.29 mmHgStandard 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 IIBaseline26.36 mmHgStandard 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 IIChange at Day 289.10 mmHgStandard 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 IIBaseline27.34 mmHgStandard 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 IIChange at Day 288.78 mmHgStandard Deviation 3.592
Taprenepag Vehicle (Stage I)Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage IIBaseline26.81 mmHgStandard Deviation 2.783
Taprenepag Vehicle (Stage I)Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage IIChange at Day 286.74 mmHgStandard Deviation 2.927
Comparison: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.17190% CI: [-0.21, 2.32]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.55390% CI: [-0.8, 1.7]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.55590% CI: [-0.8, 1.7]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.05390% CI: [0.22, 2.73]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [1.29, 3.8]ANCOVA
Comparison: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to Latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.01890% CI: [0.56, 3.07]ANCOVA
Primary

Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Taprenepag 0.0025% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I1 Participants
Taprenepag 0.005% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I2 Participants
Taprenepag 0.01% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I0 Participants
Taprenepag 0.015% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I5 Participants
Taprenepag 0.02% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I4 Participants
Taprenepag 0.03% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I9 Participants
Taprenepag Vehicle (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I3 Participants
Primary

Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II

An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.

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.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Taprenepag 0.0025% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II17 Participants
Taprenepag 0.005% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II20 Participants
Taprenepag 0.01% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II27 Participants
Taprenepag 0.015% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II24 Participants
Taprenepag 0.02% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II26 Participants
Taprenepag 0.03% (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II26 Participants
Taprenepag Vehicle (Stage I)Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II14 Participants
Secondary

Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II

IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).

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.

ArmMeasureGroupValue (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 IIDay 0: Baseline for Day 14: 1PM24.84 mmHgStandard 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 IIDay 0: Baseline for Day 7,14,28: 8AM27.59 mmHgStandard 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 IIDay 0: Baseline for Day 7: 10AM25.74 mmHgStandard 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 IIDay 0: Baseline for Day 7: 1PM24.85 mmHgStandard 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 IIDay 0: Baseline for Day 7: 4PM24.83 mmHgStandard 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 IIDay 0: Baseline for Day 14: 10AM25.70 mmHgStandard 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 IIDay 0: Baseline for Day 1: 8AM27.34 mmHgStandard 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 IIDay 0: Baseline for Day 14: 4PM24.87 mmHgStandard 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 IIDay 0: Baseline for Day 28: 10AM25.70 mmHgStandard 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 IIDay 0: Baseline for Day 28: 1PM24.84 mmHgStandard 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 IIDay 0: Baseline for Day 28: 4PM24.87 mmHgStandard 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 IIChange at Day 1: 8AM8.22 mmHgStandard 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 IIChange at Day 7: 8AM9.24 mmHgStandard 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 IIChange at Day 7: 10AM8.47 mmHgStandard 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 IIChange at Day 7: 1PM7.60 mmHgStandard 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 IIChange at Day 7: 4PM7.57 mmHgStandard 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 IIChange at Day 14: 8AM8.74 mmHgStandard 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 IIChange at Day 14: 10AM7.89 mmHgStandard 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 IIChange at Day 14: 1PM6.89 mmHgStandard 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 IIChange at Day 14: 4PM7.46 mmHgStandard 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 IIChange at Day 28: 8AM7.99 mmHgStandard 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 IIChange at Day 28: 10AM7.78 mmHgStandard 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 IIChange at Day 28: 1PM6.54 mmHgStandard 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 IIChange at Day 28: 4PM7.09 mmHgStandard 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 IIDay 0: Baseline for Day 14: 10AM26.44 mmHgStandard 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 IIDay 0: Baseline for Day 7: 10AM26.44 mmHgStandard 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 IIChange at Day 7: 10AM7.49 mmHgStandard 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 IIChange at Day 7: 8AM8.76 mmHgStandard 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 IIChange at Day 28: 1PM6.47 mmHgStandard 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 IIChange at Day 1: 8AM6.29 mmHgStandard 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 IIDay 0: Baseline for Day 7,14,28: 8AM28.16 mmHgStandard 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 IIDay 0: Baseline for Day 7: 1PM25.67 mmHgStandard 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 IIDay 0: Baseline for Day 1: 8AM28.21 mmHgStandard 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 IIDay 0: Baseline for Day 14: 1PM25.67 mmHgStandard 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 IIChange at Day 28: 10AM7.00 mmHgStandard 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 IIChange at Day 28: 8AM8.40 mmHgStandard 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 IIChange at Day 14: 4PM6.24 mmHgStandard 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 IIDay 0: Baseline for Day 14: 4PM25.59 mmHgStandard 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 IIDay 0: Baseline for Day 7: 4PM25.59 mmHgStandard 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 IIChange at Day 14: 1PM6.33 mmHgStandard 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 IIChange at Day 28: 4PM6.51 mmHgStandard 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 IIDay 0: Baseline for Day 28: 10AM26.44 mmHgStandard 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 IIChange at Day 14: 10AM6.83 mmHgStandard 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 IIChange at Day 14: 8AM8.60 mmHgStandard 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 IIDay 0: Baseline for Day 28: 1PM25.67 mmHgStandard 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 IIChange at Day 7: 4PM6.92 mmHgStandard 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 IIChange at Day 7: 1PM6.99 mmHgStandard 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 IIDay 0: Baseline for Day 28: 4PM25.59 mmHgStandard 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 IIDay 0: Baseline for Day 7: 1PM26.19 mmHgStandard 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 IIChange at Day 28: 4PM6.74 mmHgStandard 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 IIChange at Day 14: 8AM8.55 mmHgStandard 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 IIChange at Day 7: 8AM8.59 mmHgStandard 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 IIDay 0: Baseline for Day 14: 4PM25.86 mmHgStandard 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 IIChange at Day 7: 10AM8.10 mmHgStandard 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 IIChange at Day 14: 1PM7.17 mmHgStandard 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 IIChange at Day 1: 8AM7.66 mmHgStandard 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 IIDay 0: Baseline for Day 7,14,28: 8AM28.27 mmHgStandard 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 IIChange at Day 28: 1PM7.07 mmHgStandard 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 IIChange at Day 7: 4PM7.60 mmHgStandard 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 IIChange at Day 28: 10AM6.92 mmHgStandard 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 IIDay 0: Baseline for Day 28: 4PM25.86 mmHgStandard 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 IIDay 0: Baseline for Day 14: 10AM26.66 mmHgStandard 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 IIChange at Day 7: 1PM7.46 mmHgStandard 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 IIDay 0: Baseline for Day 1: 8AM28.27 mmHgStandard 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 IIChange at Day 14: 10AM7.22 mmHgStandard 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 IIChange at Day 28: 8AM8.00 mmHgStandard 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 IIDay 0: Baseline for Day 7: 10AM26.70 mmHgStandard 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 IIDay 0: Baseline for Day 28: 1PM26.13 mmHgStandard 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 IIDay 0: Baseline for Day 14: 1PM26.13 mmHgStandard 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 IIDay 0: Baseline for Day 28: 10AM26.66 mmHgStandard 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 IIDay 0: Baseline for Day 7: 4PM25.87 mmHgStandard 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 IIChange at Day 14: 4PM7.55 mmHgStandard 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 IIDay 0: Baseline for Day 7: 1PM26.04 mmHgStandard 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 IIDay 0: Baseline for Day 7: 4PM25.92 mmHgStandard 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 IIDay 0: Baseline for Day 14: 10AM26.94 mmHgStandard 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 IIChange at Day 28: 10AM8.68 mmHgStandard 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 IIDay 0: Baseline for Day 14: 1PM25.92 mmHgStandard 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 IIDay 0: Baseline for Day 14: 4PM25.99 mmHgStandard 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 IIDay 0: Baseline for Day 28: 10AM27.06 mmHgStandard 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 IIDay 0: Baseline for Day 28: 1PM25.98 mmHgStandard 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 IIDay 0: Baseline for Day 28: 4PM26.00 mmHgStandard 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 IIChange at Day 1: 8AM9.72 mmHgStandard 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 IIChange at Day 7: 8AM10.20 mmHgStandard 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 IIChange at Day 28: 1PM7.51 mmHgStandard 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 IIChange at Day 7: 10AM9.19 mmHgStandard 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 IIChange at Day 7: 1PM8.02 mmHgStandard 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 IIChange at Day 7: 4PM8.27 mmHgStandard 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 IIChange at Day 14: 8AM9.50 mmHgStandard 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 IIChange at Day 14: 10AM7.95 mmHgStandard 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 IIChange at Day 14: 1PM7.03 mmHgStandard 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 IIChange at Day 14: 4PM7.33 mmHgStandard 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 IIChange at Day 28: 4PM6.94 mmHgStandard 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 IIChange at Day 28: 8AM9.92 mmHgStandard 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 IIDay 0: Baseline for Day 1: 8AM29.10 mmHgStandard 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 IIDay 0: Baseline for Day 7,14,28: 8AM29.03 mmHgStandard 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 IIDay 0: Baseline for Day 7: 10AM27.13 mmHgStandard 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 IIDay 0: Baseline for Day 28: 10AM26.42 mmHgStandard 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 IIChange at Day 28: 1PM8.66 mmHgStandard 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 IIDay 0: Baseline for Day 7: 10AM26.42 mmHgStandard 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 IIChange at Day 14: 10AM9.76 mmHgStandard 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 IIChange at Day 7: 8AM11.22 mmHgStandard 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 IIChange at Day 28: 10AM9.55 mmHgStandard 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 IIChange at Day 14: 1PM8.83 mmHgStandard 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 IIDay 0: Baseline for Day 28: 4PM25.35 mmHgStandard 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 IIDay 0: Baseline for Day 14: 4PM25.35 mmHgStandard 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 IIDay 0: Baseline for Day 7: 1PM25.34 mmHgStandard 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 IIDay 0: Baseline for Day 28: 1PM25.34 mmHgStandard 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 IIChange at Day 1: 8AM9.87 mmHgStandard 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 IIDay 0: Baseline for Day 1: 8AM28.63 mmHgStandard 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 IIChange at Day 7: 4PM8.44 mmHgStandard 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 IIChange at Day 7: 10AM9.61 mmHgStandard 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 IIChange at Day 28: 4PM8.23 mmHgStandard 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 IIDay 0: Baseline for Day 14: 10AM26.42 mmHgStandard 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 IIChange at Day 28: 8AM10.66 mmHgStandard 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 IIDay 0: Baseline for Day 7,14,28: 8AM28.63 mmHgStandard 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 IIDay 0: Baseline for Day 7: 4PM25.35 mmHgStandard 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 IIChange at Day 14: 8AM10.94 mmHgStandard 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 IIChange at Day 7: 1PM8.54 mmHgStandard 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 IIDay 0: Baseline for Day 14: 1PM25.34 mmHgStandard 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 IIChange at Day 14: 4PM8.36 mmHgStandard 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 IIDay 0: Baseline for Day 28: 4PM26.20 mmHgStandard 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 IIDay 0: Baseline for Day 28: 1PM26.21 mmHgStandard 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 IIChange at Day 7: 1PM9.17 mmHgStandard 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 IIChange at Day 28: 1PM8.82 mmHgStandard 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 IIChange at Day 7: 4PM8.55 mmHgStandard 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 IIDay 0: Baseline for Day 28: 10AM27.41 mmHgStandard 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 IIChange at Day 14: 8AM10.52 mmHgStandard 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 IIChange at Day 28: 10AM9.74 mmHgStandard 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 IIChange at Day 14: 10AM9.56 mmHgStandard 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 IIDay 0: Baseline for Day 14: 4PM26.20 mmHgStandard 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 IIChange at Day 14: 1PM8.86 mmHgStandard 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 IIDay 0: Baseline for Day 14: 1PM26.21 mmHgStandard 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 IIChange at Day 14: 4PM7.95 mmHgStandard 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 IIDay 0: Baseline for Day 7: 10AM27.48 mmHgStandard 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 IIDay 0: Baseline for Day 14: 10AM27.41 mmHgStandard 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 IIDay 0: Baseline for Day 1: 8AM29.19 mmHgStandard 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 IIChange at Day 28: 8AM10.20 mmHgStandard 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 IIDay 0: Baseline for Day 7: 4PM26.12 mmHgStandard 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 IIChange at Day 1: 8AM9.49 mmHgStandard 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 IIChange at Day 7: 10AM10.14 mmHgStandard 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 IIDay 0: Baseline for Day 7: 1PM26.27 mmHgStandard 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 IIChange at Day 7: 8AM10.91 mmHgStandard 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 IIChange at Day 28: 4PM7.64 mmHgStandard 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 IIDay 0: Baseline for Day 7,14,28: 8AM29.19 mmHgStandard 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 IIDay 0: Baseline for Day 28: 10AM26.70 mmHgStandard 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 IIDay 0: Baseline for Day 7,14,28: 8AM28.60 mmHgStandard 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 IIChange at Day 28: 1PM6.66 mmHgStandard 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 IIChange at Day 7: 4PM6.14 mmHgStandard 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 IIChange at Day 28: 8AM7.91 mmHgStandard 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 IIDay 0: Baseline for Day 28: 1PM25.99 mmHgStandard 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 IIDay 0: Baseline for Day 1: 8AM28.55 mmHgStandard 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 IIChange at Day 7: 1PM6.69 mmHgStandard 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 IIDay 0: Baseline for Day 7: 4PM25.84 mmHgStandard 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 IIChange at Day 7: 10AM7.60 mmHgStandard 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 IIDay 0: Baseline for Day 14: 4PM25.84 mmHgStandard 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 IIChange at Day 7: 8AM8.50 mmHgStandard 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 IIChange at Day 14: 1PM7.16 mmHgStandard 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 IIChange at Day 14: 10AM7.30 mmHgStandard 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 IIDay 0: Baseline for Day 14: 1PM25.99 mmHgStandard 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 IIChange at Day 1: 8AM8.16 mmHgStandard 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 IIDay 0: Baseline for Day 7: 1PM25.99 mmHgStandard 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 IIChange at Day 28: 4PM5.79 mmHgStandard 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 IIChange at Day 28: 10AM7.06 mmHgStandard 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 IIChange at Day 14: 4PM6.30 mmHgStandard 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 IIDay 0: Baseline for Day 28: 4PM25.84 mmHgStandard 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 IIChange at Day 14: 8AM8.94 mmHgStandard 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 IIDay 0: Baseline for Day 14: 10AM26.70 mmHgStandard 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 IIDay 0: Baseline for Day 7: 10AM26.70 mmHgStandard Deviation 3.25
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.37790% CI: [-0.63, 2.08]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.03990% CI: [-3.01, -0.35]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.66890% CI: [-1.67, 0.98]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.12190% CI: [-0.07, 2.59]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.03990% CI: [0.34, 2.99]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.2290% CI: [-0.34, 2.31]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.09890% CI: [0.01, 2.59]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.51990% CI: [-0.77, 1.77]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.72490% CI: [-1, 1.55]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.05990% CI: [0.19, 2.74]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [1.43, 3.98]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00890% CI: [0.82, 3.37]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.06890% CI: [0.13, 2.51]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.99490% CI: [-1.16, 1.18]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.49490% CI: [-0.7, 1.69]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.06390% CI: [0.16, 2.62]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00490% CI: [0.95, 3.34]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00490% CI: [0.97, 3.38]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.03890% CI: [0.32, 2.77]ANCOVA
Comparison: Change at Day 7 1 PM : Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.51290% CI: [-0.72, 1.68]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.37390% CI: [-0.56, 1.89]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.08890% CI: [0.05, 2.56]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00490% CI: [0.98, 3.44]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00390% CI: [1.09, 3.57]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.0190% CI: [0.69, 3.04]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.20590% CI: [-0.27, 2.05]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.04590% CI: [0.26, 2.63]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00590% CI: [0.88, 3.31]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [1.33, 3.7]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [1.1, 3.48]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.75790% CI: [-1.15, 1.69]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.87890% CI: [-1.54, 1.27]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.7890% CI: [-1.64, 1.17]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.6790% CI: [-1.04, 1.77]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.02190% CI: [0.58, 3.38]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.12690% CI: [-0.1, 2.71]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.21590% CI: [-0.32, 2.26]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.63590% CI: [-1.65, 0.91]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.93490% CI: [-1.35, 1.22]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.47890% CI: [-0.74, 1.87]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [1.26, 3.87]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.01390% CI: [0.68, 3.3]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.73690% CI: [-1.04, 1.57]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.38690% CI: [-1.96, 0.61]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.94890% CI: [-1.35, 1.24]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.90890% CI: [-1.41, 1.22]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.01590% CI: [0.65, 3.28]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.04690% CI: [0.29, 2.92]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.04290% CI: [0.31, 2.89]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.9490% CI: [-1.22, 1.34]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.11490% CI: [-0.05, 2.53]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.22890% CI: [-0.35, 2.28]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00590% CI: [0.98, 3.6]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.06390% CI: [0.17, 2.79]ANCOVA
Comparison: Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.56290% CI: [-0.92, 1.91]ANCOVA
Comparison: Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.43190% CI: [-0.73, 2.07]ANCOVA
Comparison: Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.79590% CI: [-1.18, 1.62]ANCOVA
Comparison: Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.03290% CI: [0.43, 3.23]ANCOVA
Comparison: Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [1.34, 4.13]ANCOVA
Comparison: Change at Day 28 8 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.01790% CI: [0.64, 3.44]ANCOVA
Comparison: Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.12490% CI: [-0.09, 2.6]ANCOVA
Comparison: Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.9290% CI: [-1.25, 1.41]ANCOVA
Comparison: Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.88790% CI: [-1.46, 1.22]ANCOVA
Comparison: Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.08390% CI: [0.08, 2.77]ANCOVA
Comparison: Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [1.29, 4.01]ANCOVA
Comparison: Change at Day 28 10 AM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00690% CI: [0.94, 3.66]ANCOVA
Comparison: Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.53390% CI: [-0.8, 1.78]ANCOVA
Comparison: Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.98590% CI: [-1.29, 1.26]ANCOVA
Comparison: Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.66590% CI: [-0.95, 1.62]ANCOVA
Comparison: Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.27690% CI: [-0.44, 2.15]ANCOVA
Comparison: Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00490% CI: [1.04, 3.65]ANCOVA
Comparison: Change at Day 28 1 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.01190% CI: [0.74, 3.35]ANCOVA
Comparison: Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.03390% CI: [0.41, 3.14]ANCOVA
Comparison: Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.30290% CI: [-0.5, 2.19]ANCOVA
Comparison: Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag alone compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.25590% CI: [-0.42, 2.3]ANCOVA
Comparison: Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.19890% CI: [-0.3, 2.46]ANCOVA
Comparison: Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [1.3, 4.06]ANCOVA
Comparison: Change at Day 28 4 PM: Analysis was based on ANCOVA model for effect of taprenepag in combination with latanoprost compared to latanoprost alone on IOP reduction from baseline with treatment and baseline IOP as covariates.p-value: 0.04690% CI: [0.3, 3.06]ANCOVA
Secondary

Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I

IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).

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.

ArmMeasureGroupValue (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 IDay 0:Baseline for Day 14 1 PM25.83 mmHgStandard 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 IDay 0:Baseline for Day 14 10 AM24.75 mmHgStandard 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 IDay 0: Baseline for Day 7 4 PM25.50 mmHgStandard 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 IChange at Day 14 1 PM4.56 mmHgStandard 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 IChange at Day 14 10 AM3.86 mmHgStandard 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 IChange at Day 14 8 AM3.44 mmHgStandard 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 IDay 0: Baseline for Day 7 10 AM24.75 mmHgStandard 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 IDay0: Baseline for Day 1, 7, 14 8 AM27.78 mmHgStandard 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 IChange at Day 7 4 PM4.33 mmHgStandard 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 IChange at Day 7 1 PM4.67 mmHgStandard 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 IChange at Day 7 10 AM3.58 mmHgStandard 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 IChange at Day 7 8 AM4.56 mmHgStandard 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 IChange at Day 1 8 AM4.89 mmHgStandard 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 IDay 0: Baseline for Day 7 1 PM25.83 mmHgStandard 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 IChange at Day 14 4 PM2.72 mmHgStandard 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 IDay 0:Baseline for Day 14 4 PM25.50 mmHgStandard 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 IChange at Day 7 1 PM6.22 mmHgStandard 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 IDay 0: Baseline for Day 7 10 AM26.11 mmHgStandard 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 IDay 0: Baseline for Day 7 1 PM26.06 mmHgStandard 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 IDay 0: Baseline for Day 7 4 PM25.11 mmHgStandard 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 IDay 0:Baseline for Day 14 10 AM26.11 mmHgStandard 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 IDay 0:Baseline for Day 14 1 PM26.06 mmHgStandard 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 IDay 0:Baseline for Day 14 4 PM25.11 mmHgStandard 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 IChange at Day 1 8 AM5.44 mmHgStandard 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 IChange at Day 7 8 AM6.67 mmHgStandard 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 IChange at Day 7 10 AM7.00 mmHgStandard 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 IDay0: Baseline for Day 1, 7, 14 8 AM27.72 mmHgStandard 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 IChange at Day 7 4 PM5.06 mmHgStandard 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 IChange at Day 14 8 AM6.11 mmHgStandard 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 IChange at Day 14 10 AM6.33 mmHgStandard 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 IChange at Day 14 1 PM5.22 mmHgStandard 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 IChange at Day 14 4 PM3.94 mmHgStandard 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 IChange at Day 7 10 AM7.56 mmHgStandard 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 IDay 0:Baseline for Day 14 10 AM25.94 mmHgStandard 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 IDay 0: Baseline for Day 7 10 AM25.94 mmHgStandard 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 IChange at Day 14 4 PM6.08 mmHgStandard 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 IChange at Day 7 1 PM7.86 mmHgStandard 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 IDay 0: Baseline for Day 7 1 PM25.08 mmHgStandard 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 IDay 0:Baseline for Day 14 4 PM24.86 mmHgStandard 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 IDay 0: Baseline for Day 7 4 PM24.86 mmHgStandard 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 IChange at Day 14 1 PM6.53 mmHgStandard 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 IChange at Day 14 10 AM7.67 mmHgStandard 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 IChange at Day 1 8 AM7.72 mmHgStandard 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 IDay 0:Baseline for Day 14 1 PM25.08 mmHgStandard 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 IChange at Day 14 8 AM8.44 mmHgStandard 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 IChange at Day 7 8 AM8.28 mmHgStandard 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 IChange at Day 7 4 PM7.25 mmHgStandard 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 IDay0: Baseline for Day 1, 7, 14 8 AM27.72 mmHgStandard 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 IChange at Day 14 10 AM6.40 mmHgStandard 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 IChange at Day 7 10 AM7.15 mmHgStandard 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 IChange at Day 14 4 PM6.30 mmHgStandard 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 IChange at Day 7 8 AM8.20 mmHgStandard 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 IChange at Day 7 1 PM7.55 mmHgStandard 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 IDay 0: Baseline for Day 7 10 AM26.30 mmHgStandard 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 IChange at Day 1 8 AM6.75 mmHgStandard 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 IDay 0:Baseline for Day 14 1 PM25.10 mmHgStandard 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 IChange at Day 14 1 PM5.50 mmHgStandard 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 IChange at Day 14 8 AM7.70 mmHgStandard 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 IDay 0: Baseline for Day 7 4 PM25.90 mmHgStandard 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 IDay 0: Baseline for Day 7 1 PM25.10 mmHgStandard 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 IDay 0:Baseline for Day 14 4 PM25.90 mmHgStandard 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 IDay 0:Baseline for Day 14 10 AM26.30 mmHgStandard 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 IChange at Day 7 4 PM8.95 mmHgStandard 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 IDay0: Baseline for Day 1, 7, 14 8 AM28.45 mmHgStandard 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 IDay 0:Baseline for Day 14 10 AM27.44 mmHgStandard 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 IChange at Day 14 1 PM5.14 mmHgStandard 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 IDay 0:Baseline for Day 14 1 PM28.03 mmHgStandard 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 IDay 0:Baseline for Day 14 4 PM27.11 mmHgStandard 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 IChange at Day 1 8 AM7.75 mmHgStandard 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 IChange at Day 7 8 AM9.58 mmHgStandard 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 IDay 0: Baseline for Day 7 10 AM26.53 mmHgStandard 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 IChange at Day 7 10 AM6.16 mmHgStandard 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 IChange at Day 7 1 PM6.50 mmHgStandard 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 IChange at Day 7 4 PM5.53 mmHgStandard 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 IChange at Day 14 4 PM6.44 mmHgStandard 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 IChange at Day 14 8 AM6.86 mmHgStandard 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 IChange at Day 14 10 AM5.56 mmHgStandard 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 IDay0: Baseline for Day 1, 7, 14 8 AM29.81 mmHgStandard 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 IDay 0: Baseline for Day 7 4 PM26.41 mmHgStandard 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 IDay 0: Baseline for Day 7 1 PM27.13 mmHgStandard 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 IDay 0: Baseline for Day 7 4 PM25.28 mmHgStandard 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 IChange at Day 7 4 PM6.66 mmHgStandard 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 IChange at Day 1 8 AM7.22 mmHgStandard 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 IDay 0:Baseline for Day 14 10 AM26.16 mmHgStandard 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 IChange at Day 14 8 AM8.28 mmHgStandard 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 IDay0: Baseline for Day 1, 7, 14 8 AM28.44 mmHgStandard 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 IChange at Day 14 4 PM6.22 mmHgStandard 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 IChange at Day 14 10 AM8.09 mmHgStandard 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 IDay 0:Baseline for Day 14 1 PM25.69 mmHgStandard 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 IDay 0: Baseline for Day 7 1 PM25.69 mmHgStandard 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 IDay 0:Baseline for Day 14 4 PM25.28 mmHgStandard 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 IChange at Day 14 1 PM7.19 mmHgStandard 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 IChange at Day 7 1 PM7.44 mmHgStandard 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 IChange at Day 7 10 AM8.72 mmHgStandard 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 IChange at Day 7 8 AM7.67 mmHgStandard 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 IDay 0: Baseline for Day 7 10 AM26.16 mmHgStandard 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 IChange at Day 14 10 AM0.67 mmHgStandard 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 IChange at Day 7 10 AM-0.33 mmHgStandard 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 IChange at Day 7 4 PM-0.23 mmHgStandard 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 IDay0: Baseline for Day 1, 7, 14 8 AM28.15 mmHgStandard 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 IDay 0: Baseline for Day 7 4 PM25.35 mmHgStandard 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 IChange at Day 1 8 AM1.35 mmHgStandard 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 IChange at Day 14 4 PM0.27 mmHgStandard 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 IDay 0: Baseline for Day 7 1 PM25.52 mmHgStandard 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 IDay 0:Baseline for Day 14 10 AM25.13 mmHgStandard 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 IChange at Day 14 8 AM1.56 mmHgStandard 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 IDay 0:Baseline for Day 14 4 PM25.35 mmHgStandard 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 IChange at Day 7 8 AM2.15 mmHgStandard 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 IChange at Day 14 1 PM0.06 mmHgStandard 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 IDay 0: Baseline for Day 7 10 AM25.13 mmHgStandard 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 IDay 0:Baseline for Day 14 1 PM25.52 mmHgStandard 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 IChange at Day 7 1 PM1.90 mmHgStandard Deviation 2.546
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.01190% CI: [1.34, 5.9]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00490% CI: [1.91, 6.47]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.19, 8.75]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.11, 7.54]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.66, 8.33]ANCOVA
Comparison: Change at Day 1 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.52, 8.08]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.1290% CI: [-0.14, 5.02]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00590% CI: [1.97, 7.14]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.58, 8.75]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.52, 8.54]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.66, 9.95]ANCOVA
Comparison: Change at Day 7 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its Vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [2.91, 8.08]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00990% CI: [1.56, 6.53]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.49, 9.5]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [5.11, 10.11]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.64, 9.53]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.4, 8.62]ANCOVA
Comparison: Change at Day 7 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [6.11, 11.3]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.06690% CI: [0.29, 5.02]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00690% CI: [1.76, 6.5]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.76, 8.49]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.51, 8.11]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.0190% CI: [1.53, 6.5]ANCOVA
Comparison: Change at Day 7 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.03, 7.93]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00690% CI: [1.91, 7.19]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [2.66, 7.94]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.87, 10.16]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [6.57, 11.71]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [2.94, 8.44]ANCOVA
Comparison: Change at Day 7 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.16, 9.62]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.26990% CI: [-0.91, 4.58]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00990% CI: [1.75, 7.24]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.08, 9.57]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.52, 8.84]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00290% CI: [2.71, 8.33]ANCOVA
Comparison: Change at Day 14 8 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.01, 9.5]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.02490% CI: [0.95, 5.76]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [2.82, 7.66]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.23, 9.06]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [2.87, 7.58]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.01290% CI: [1.39, 6.37]ANCOVA
Comparison: Change at Day 14 10 AM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.48, 9.48]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00390% CI: [2.11, 6.72]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [2.72, 7.33]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.27, 8.88]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.31, 7.78]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.00390% CI: [2.06, 6.82]ANCOVA
Comparison: Change at Day 14 1 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [4.7, 9.47]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.10390% CI: [-0.02, 4.84]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: 0.01390% CI: [1.32, 6.18]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.53, 8.39]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.5, 8.23]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.18, 8.11]ANCOVA
Comparison: Change at Day 14 4 PM: Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.p-value: <0.00190% CI: [3.46, 8.48]ANCOVA
Secondary

Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I

IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.

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.

ArmMeasureGroupValue (MEAN)Dispersion
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 1 PM21.17 mmHgStandard Deviation 2.525
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 10 AM20.89 mmHgStandard Deviation 1.635
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 10 AM21.17 mmHgStandard Deviation 2.165
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 4 PM21.17 mmHgStandard Deviation 3.491
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 1 PM21.28 mmHgStandard Deviation 2.078
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 8 AM24.33 mmHgStandard Deviation 4.737
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 4 PM22.78 mmHgStandard Deviation 3.914
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 8 AM23.22 mmHgStandard Deviation 3.563
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 1: 8 AM22.89 mmHgStandard Deviation 3.14
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 8 AM21.61 mmHgStandard Deviation 3.927
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 4 PM20.06 mmHgStandard Deviation 5.282
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 4 PM21.17 mmHgStandard Deviation 3.841
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 8 AM21.06 mmHgStandard Deviation 2.888
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 1 PM20.83 mmHgStandard Deviation 2.839
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 10 AM19.11 mmHgStandard Deviation 3.943
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 1: 8 AM22.28 mmHgStandard Deviation 3.709
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 10 AM19.78 mmHgStandard Deviation 2.74
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 1 PM19.83 mmHgStandard Deviation 3.269
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 10 AM18.28 mmHgStandard Deviation 3.501
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 4 PM17.61 mmHgStandard Deviation 3.935
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 1: 8 AM20.00 mmHgStandard Deviation 1.677
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 8 AM19.44 mmHgStandard Deviation 4.081
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 8 AM19.28 mmHgStandard Deviation 2.438
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 1 PM18.56 mmHgStandard Deviation 3.754
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 1 PM17.22 mmHgStandard Deviation 4.063
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 10 AM18.39 mmHgStandard Deviation 3.11
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 4 PM18.78 mmHgStandard Deviation 3.97
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 8 AM20.75 mmHgStandard Deviation 4.906
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 1: 8 AM21.70 mmHgStandard Deviation 3.425
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 8 AM20.25 mmHgStandard Deviation 4.584
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 10 AM19.15 mmHgStandard Deviation 4.429
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 1 PM17.55 mmHgStandard Deviation 3.905
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 4 PM16.95 mmHgStandard Deviation 3.954
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 10 AM19.90 mmHgStandard Deviation 4.858
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 1 PM19.60 mmHgStandard Deviation 5.254
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 4 PM19.60 mmHgStandard Deviation 5.004
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 10 AM20.38 mmHgStandard Deviation 2.888
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 1: 8 AM22.06 mmHgStandard Deviation 2.732
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 10 AM21.89 mmHgStandard Deviation 3.798
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 1 PM22.89 mmHgStandard Deviation 4.029
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 1 PM20.63 mmHgStandard Deviation 4.224
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 8 AM22.94 mmHgStandard Deviation 3.787
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 8 AM20.22 mmHgStandard Deviation 3.866
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 4 PM20.67 mmHgStandard Deviation 2.704
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 4 PM20.88 mmHgStandard Deviation 4.604
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 4 PM19.06 mmHgStandard Deviation 3.886
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 1 PM18.50 mmHgStandard Deviation 3.703
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 1: 8 AM21.22 mmHgStandard Deviation 4.214
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 4 PM18.63 mmHgStandard Deviation 3.926
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 10 AM17.44 mmHgStandard Deviation 3.803
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 10 AM18.06 mmHgStandard Deviation 4.724
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 1 PM18.25 mmHgStandard Deviation 4.359
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 8 AM20.78 mmHgStandard Deviation 3.42
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 8 AM20.17 mmHgStandard Deviation 5.75
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 8 AM26.00 mmHgStandard Deviation 4.843
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 10 AM24.46 mmHgStandard Deviation 2.463
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 8 AM26.58 mmHgStandard Deviation 4.592
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 10 AM25.46 mmHgStandard Deviation 4.293
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 1 PM23.63 mmHgStandard Deviation 2.909
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 4 PM25.08 mmHgStandard Deviation 3.154
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 14: 1 PM25.46 mmHgStandard Deviation 3.665
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 1: 8 AM26.79 mmHgStandard Deviation 4.335
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IDay 7: 4 PM25.58 mmHgStandard Deviation 5.044
Secondary

Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II

IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.

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.

ArmMeasureGroupValue (MEAN)Dispersion
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 8 AM18.34 mmHgStandard Deviation 3.115
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 10 AM17.26 mmHgStandard Deviation 2.456
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 4 PM17.79 mmHgStandard Deviation 3.673
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 1: 8 AM19.12 mmHgStandard Deviation 3.514
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 8 AM19.60 mmHgStandard Deviation 3.794
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 8 AM18.85 mmHgStandard Deviation 3.439
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 4 PM17.41 mmHgStandard Deviation 3.452
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 1 PM18.30 mmHgStandard Deviation 3.787
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 1 PM17.25 mmHgStandard Deviation 3.184
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 4 PM17.26 mmHgStandard Deviation 2.962
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 10 AM17.93 mmHgStandard Deviation 3.341
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 1 PM17.94 mmHgStandard Deviation 3.912
Taprenepag 0.0025% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 10 AM17.81 mmHgStandard Deviation 3.848
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 10 AM19.61 mmHgStandard Deviation 4.209
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 8 AM19.56 mmHgStandard Deviation 3.288
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 4 PM18.67 mmHgStandard Deviation 3.69
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 1 PM19.19 mmHgStandard Deviation 3.092
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 8 AM19.40 mmHgStandard Deviation 3.308
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 1: 8 AM21.91 mmHgStandard Deviation 3.177
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 10 AM19.44 mmHgStandard Deviation 3.335
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 8 AM19.76 mmHgStandard Deviation 3.188
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 10 AM18.96 mmHgStandard Deviation 3.938
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 4 PM19.35 mmHgStandard Deviation 4.035
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 1 PM19.33 mmHgStandard Deviation 3.619
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 1 PM18.68 mmHgStandard Deviation 3.122
Taprenepag 0.005% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 4 PM19.08 mmHgStandard Deviation 3.394
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 4 PM19.13 mmHgStandard Deviation 4.396
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 1: 8 AM20.61 mmHgStandard Deviation 2.859
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 8 AM19.68 mmHgStandard Deviation 3.14
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 10 AM18.61 mmHgStandard Deviation 2.814
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 1 PM18.73 mmHgStandard Deviation 3.518
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 4 PM18.27 mmHgStandard Deviation 3.047
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 8 AM19.72 mmHgStandard Deviation 3.644
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 10 AM19.44 mmHgStandard Deviation 3.318
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 1 PM18.96 mmHgStandard Deviation 3.776
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 4 PM18.31 mmHgStandard Deviation 3.37
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 8 AM20.28 mmHgStandard Deviation 4.294
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 10 AM19.74 mmHgStandard Deviation 3.764
Taprenepag 0.01% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 1 PM19.06 mmHgStandard Deviation 3.399
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 1 PM18.89 mmHgStandard Deviation 3.219
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 8 AM19.53 mmHgStandard Deviation 3.572
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 8 AM19.11 mmHgStandard Deviation 3.28
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 10 AM17.94 mmHgStandard Deviation 2.551
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 4 PM18.66 mmHgStandard Deviation 3.117
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 4 PM17.65 mmHgStandard Deviation 2.998
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 10 AM18.98 mmHgStandard Deviation 3.318
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 1 PM18.47 mmHgStandard Deviation 2.396
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 1: 8 AM19.39 mmHgStandard Deviation 3.229
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 8 AM18.83 mmHgStandard Deviation 2.908
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 1 PM18.02 mmHgStandard Deviation 2.872
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 10 AM18.38 mmHgStandard Deviation 3.038
Taprenepag 0.015% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 4 PM19.06 mmHgStandard Deviation 2.772
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 4 PM16.91 mmHgStandard Deviation 4.32
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 1 PM16.80 mmHgStandard Deviation 4.219
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 1: 8 AM18.76 mmHgStandard Deviation 4.058
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 10 AM16.66 mmHgStandard Deviation 4.743
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 1 PM16.52 mmHgStandard Deviation 4.622
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 10 AM16.80 mmHgStandard Deviation 4.67
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 4 PM17.12 mmHgStandard Deviation 4.823
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 4 PM16.98 mmHgStandard Deviation 5.077
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 8 AM17.97 mmHgStandard Deviation 4.876
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 8 AM17.41 mmHgStandard Deviation 4.035
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 10 AM16.86 mmHgStandard Deviation 4.827
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 1 PM16.68 mmHgStandard Deviation 5.331
Taprenepag 0.02% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 8 AM17.69 mmHgStandard Deviation 4.58
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 8 AM18.99 mmHgStandard Deviation 3.644
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 10 AM17.85 mmHgStandard Deviation 3.282
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 1 PM17.09 mmHgStandard Deviation 3.057
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 1: 8 AM19.69 mmHgStandard Deviation 3.945
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 1 PM17.39 mmHgStandard Deviation 2.68
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 10 AM17.67 mmHgStandard Deviation 3.196
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 8 AM18.67 mmHgStandard Deviation 4.127
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 10 AM17.34 mmHgStandard Deviation 3.028
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 4 PM17.56 mmHgStandard Deviation 2.989
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 4 PM18.26 mmHgStandard Deviation 2.736
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 1 PM17.35 mmHgStandard Deviation 2.612
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 8 AM18.28 mmHgStandard Deviation 3.718
Taprenepag 0.03% (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 4 PM18.56 mmHgStandard Deviation 3.323
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 8 AM20.10 mmHgStandard Deviation 3.698
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 4 PM19.70 mmHgStandard Deviation 3.642
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 8 AM20.69 mmHgStandard Deviation 3.577
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 8 AM19.66 mmHgStandard Deviation 3.908
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 4 PM20.06 mmHgStandard Deviation 3.668
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 10 AM19.10 mmHgStandard Deviation 3.727
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 7: 1 PM19.30 mmHgStandard Deviation 3.032
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 10 AM19.64 mmHgStandard Deviation 3.966
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 10 AM19.40 mmHgStandard Deviation 3.485
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 1: 8 AM20.39 mmHgStandard Deviation 3.548
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 28: 1 PM19.33 mmHgStandard Deviation 3.204
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 4 PM19.54 mmHgStandard Deviation 3.361
Taprenepag Vehicle (Stage I)Mean Intra Ocular Pressure (IOP) in Study Eye: Stage IIDay 14: 1 PM18.83 mmHgStandard Deviation 3.231
Secondary

Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I

Percentage of participants who reached an IOP of less than or equal to (\<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.

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.

ArmMeasureValue (NUMBER)
Taprenepag 0.0025% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I0.0 percentage of participants
Taprenepag 0.005% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I11.1 percentage of participants
Taprenepag 0.01% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I11.1 percentage of participants
Taprenepag 0.015% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I0.0 percentage of participants
Taprenepag 0.02% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I11.1 percentage of participants
Taprenepag 0.03% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I22.2 percentage of participants
Taprenepag Vehicle (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I0.0 percentage of participants
Secondary

Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II

Percentage of participants who reached an IOP \<= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.

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.

ArmMeasureValue (NUMBER)
Taprenepag 0.0025% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II22.9 percentage of participants
Taprenepag 0.005% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II2.8 percentage of participants
Taprenepag 0.01% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II13.9 percentage of participants
Taprenepag 0.015% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II8.3 percentage of participants
Taprenepag 0.02% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II38.9 percentage of participants
Taprenepag 0.03% (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II16.7 percentage of participants
Taprenepag Vehicle (Stage I)Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II5.7 percentage of participants

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026