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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00572455
Collaborator
(none)
318
23
14
18.5
13.8
0.7

Study Details

Study Description

Brief Summary

To evaluate the safety and efficacy of PF-04217329.

Condition or Disease Intervention/Treatment Phase
  • Drug: PF-04217329 - Lowest Dose
  • Drug: PF-04217329 - Low Dose
  • Drug: PF-04217329 - Middle Dose
  • Drug: PF-04217329 - High Middle Dose
  • Drug: PF-04217329 - High Dose
  • Drug: PF-4217329 - Highest Dose
  • Drug: PF-04217329 - Vehicle
  • Drug: Latanoprost Vehicle
  • Drug: PF-04217329 - Low Dose
  • Drug: Latanoprost Vehicle
  • Drug: PF-04217329 - Middle Dose
  • Drug: Latanoprost Vehicle
  • Drug: PF-04217329 - High Dose
  • Drug: Latanoprost 0.005%
  • Drug: PF-04217329 - Low Dose
  • Drug: Latanoprost 0.005%
  • Drug: PF-04217329 - Middle Dose
  • Drug: Latanoprost 0.005%
  • Drug: PF-04217329 - High Dose
  • Drug: Latanoprost 0.005%
  • Drug: PF-04217329 - Vehicle
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
318 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 11, 2007
Actual Primary Completion Date :
Jun 26, 2009
Actual Study Completion Date :
Jun 26, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Stage 1: PF-04217329 - Lowest Dose

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

Experimental: Stage 1: PF-04217329 - Low Dose

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

Experimental: Stage 1: PF-04217329 - Middle Dose

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

Experimental: Stage 1: PF-04217329 - High Middle Dose

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

Experimental: Stage 1: PF-04217329 - High Dose

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

Experimental: Stage 1: PF-02417329 - Highest Dose

Drug: PF-4217329 - Highest Dose
1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.

Experimental: Stage 1: PF-04217329 - Vehicle

Drug: PF-04217329 - Vehicle
1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.

Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle

Drug: Latanoprost Vehicle
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

Drug: PF-04217329 - Low Dose
Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.

Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle

Drug: Latanoprost Vehicle
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

Drug: PF-04217329 - Middle Dose
Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.

Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle

Drug: Latanoprost Vehicle
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.

Drug: PF-04217329 - High Dose
Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.

Experimental: Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005%

Drug: Latanoprost 0.005%
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Drug: PF-04217329 - Low Dose
Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.

Experimental: Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005%

Drug: Latanoprost 0.005%
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Drug: PF-04217329 - Middle Dose
Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.

Experimental: Stage 2: PF-04217329 - High Dose + Latanoprost 0.005%

Drug: Latanoprost 0.005%
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Drug: PF-04217329 - High Dose
Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.

Experimental: Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005%

Drug: Latanoprost 0.005%
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.

Drug: PF-04217329 - Vehicle
Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.

Outcome Measures

Primary Outcome Measures

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

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

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

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

  3. Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I [Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)]

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

  4. Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II [Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)]

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

Secondary Outcome Measures

  1. Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I [Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14]

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

  2. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I [Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14]

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

  3. Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II [Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28]

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

  4. Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II [Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28]

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

  5. Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I [Stage I: Day 1 up to Day 14]

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

  6. Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II [Stage II: Day 1 up to Day 28]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sall Research Medical Center Artesia California United States 90701
2 Eye Research Foundation Newport Beach California United States 92663
3 North Bay Eye Associates, Inc. Petaluma California United States 94954
4 Centre For Health Care Poway California United States 92064
5 Atlantic Institute of Clinical Research Daytona Beach Florida United States 32114
6 Florida Health Care Plans Daytona Beach Florida United States 32114
7 Eye Associates of Fort Myers Fort Myers Florida United States 33901
8 International Eye Associates, PA Ormond Beach Florida United States 32174
9 Coastal Research Associates,LLC Atlanta Georgia United States 30339
10 Omni Eye Services of Atlanta Atlanta Georgia United States 30342
11 Eye Care Centers Management, Inc. Morrow Georgia United States 30260
12 The Eye Group of Southern Indiana Evansville Indiana United States 47710
13 Taustine Eye Center Louisville Kentucky United States 40217
14 Rochester Ophthalmological Group, PC Rochester New York United States 14618
15 Charlotte Eye Ear Nose and Throat Associates, PA Charlotte North Carolina United States 28210
16 Cornerstone Eye Care High Point North Carolina United States 27262
17 Mark J. Weiss, MD. Inc. Tulsa Oklahoma United States 74104
18 Glaucoma Care Center at Century Eye Care Bristol Pennsylvania United States 19007
19 Wills Eye Institute Philadelphia Pennsylvania United States 19107
20 Bluestein Custom Vision Charleston South Carolina United States 29414-5893
21 Total Eye Care, PA Memphis Tennessee United States 38119
22 Texan Eye Care, PA Austin Texas United States 78746
23 Eye Physicians of Austin Austin Texas United States 78756

Sponsors and Collaborators

  • Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00572455
Other Study ID Numbers:
  • A0191001
First Posted:
Dec 13, 2007
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Keywords provided by Pfizer
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I) Latanoprost Vehicle and Taprenepag 0.005% (Stage II) Latanoprost Vehicle and Taprenepag 0.01% (Stage II) Latanoprost Vehicle and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag 0.005% (Stage II) Latanoprost 0.005% and Taprenepag 0.01% (Stage II) Latanoprost 0.005% and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
Period Title: Stage I (14 Days)
STARTED 9 9 9 10 9 9 12 0 0 0 0 0 0 0
COMPLETED 9 9 9 10 8 6 12 0 0 0 0 0 0 0
NOT COMPLETED 0 0 0 0 1 3 0 0 0 0 0 0 0 0
Period Title: Stage I (14 Days)
STARTED 0 0 0 0 0 0 0 35 36 36 36 36 36 36
Treated 0 0 0 0 0 0 0 35 36 36 36 36 36 35
COMPLETED 0 0 0 0 0 0 0 34 33 33 31 32 31 34
NOT COMPLETED 0 0 0 0 0 0 0 1 3 3 5 4 5 2

Baseline Characteristics

Arm/Group Title Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I) Latanoprost Vehicle and Taprenepag 0.005% (Stage II) Latanoprost Vehicle and Taprenepag 0.01% (Stage II) Latanoprost Vehicle and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag 0.005% (Stage II) Latanoprost 0.005% and Taprenepag 0.01% (Stage II) Latanoprost 0.005% and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag Vehicle (Stage II) Total
Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Total of all reporting groups
Overall Participants 9 9 9 10 9 9 12 35 36 36 36 36 36 35 317
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
59.1
(13.0)
59.1
(8.1)
64.1
(6.8)
51.8
(10.4)
64.6
(9.6)
60.3
(8.5)
62.1
(6.5)
62.5
(10.7)
63.8
(11.4)
66.6
(10.1)
66.7
(11.4)
64.1
(9.1)
63.7
(9.4)
68.9
(10.2)
64.1
(10.5)
Sex: Female, Male (Count of Participants)
Female
4
44.4%
7
77.8%
6
66.7%
10
100%
3
33.3%
6
66.7%
8
66.7%
25
71.4%
22
61.1%
21
58.3%
24
66.7%
25
69.4%
21
58.3%
22
62.9%
204
64.4%
Male
5
55.6%
2
22.2%
3
33.3%
0
0%
6
66.7%
3
33.3%
4
33.3%
10
28.6%
14
38.9%
15
41.7%
12
33.3%
11
30.6%
15
41.7%
13
37.1%
113
35.6%

Outcome Measures

1. Primary Outcome
Title Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. Last observation carried forward (LOCF) method was used to impute missing values.
Arm/Group Title Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 9 9 9 10 9 9 12
Baseline
25.97
(2.420)
26.25
(2.400)
25.90
(2.094)
26.44
(1.560)
28.10
(3.102)
26.26
(1.831)
26.04
(2.182)
Change at Day 14
3.65
(1.749)
5.40
(2.508)
7.18
(2.749)
6.48
(4.278)
6.00
(2.748)
6.69
(4.563)
0.64
(1.382)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments Analysis was based on analysis of covariance (ANCOVA) model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.028
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter Least squares (LS) mean difference
Estimated Value 3.02
Confidence Interval (2-Sided) 90%
0.78 to 5.25
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.73
Confidence Interval (2-Sided) 90%
2.50 to 6.96
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.56
Confidence Interval (2-Sided) 90%
4.33 to 8.79
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.78
Confidence Interval (2-Sided) 90%
3.60 to 7.95
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.06
Confidence Interval (2-Sided) 90%
2.74 to 7.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments Analysis was based on ANCOVA model for effect of taprenepag compared to its vehicle with treatment and baseline IOP as covariates.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.02
Confidence Interval (2-Sided) 90%
3.79 to 8.25
Parameter Dispersion Type:
Value:
Estimation Comments
2. Primary Outcome
Title Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
Arm/Group Title 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)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 35 36 36 36 36 36 35
Baseline
25.75
(2.266)
26.47
(2.563)
26.69
(2.509)
26.98
(2.813)
26.36
(2.524)
27.34
(2.876)
26.81
(2.783)
Change at Day 28
7.35
(3.559)
7.05
(2.875)
7.14
(3.462)
8.29
(3.817)
9.10
(3.292)
8.78
(3.592)
6.74
(2.927)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.171
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.06
Confidence Interval (2-Sided) 90%
-0.21 to 2.32
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.553
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.45
Confidence Interval (2-Sided) 90%
-0.80 to 1.70
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.555
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.45
Confidence Interval (2-Sided) 90%
-0.80 to 1.70
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.053
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.48
Confidence Interval (2-Sided) 90%
0.22 to 2.73
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.54
Confidence Interval (2-Sided) 90%
1.29 to 3.80
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.018
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.81
Confidence Interval (2-Sided) 90%
0.56 to 3.07
Parameter Dispersion Type:
Value:
Estimation Comments
3. Primary Outcome
Title Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
Description An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. 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)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title Taprenepag 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)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 9 9 9 10 9 9 12
Count of Participants [Participants]
1
11.1%
2
22.2%
0
0%
5
50%
4
44.4%
9
100%
3
25%
4. Primary Outcome
Title Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
Description 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)

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication.
Arm/Group Title 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)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 35 36 36 36 36 36 35
Count of Participants [Participants]
17
188.9%
20
222.2%
27
300%
24
240%
26
288.9%
26
288.9%
14
116.7%
5. Secondary Outcome
Title Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Arm/Group Title Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 9 9 9 10 9 9 12
Day 1: 8 AM
22.89
(3.140)
22.28
(3.709)
20.00
(1.677)
21.70
(3.425)
22.06
(2.732)
21.22
(4.214)
26.79
(4.335)
Day 7: 8 AM
23.22
(3.563)
21.06
(2.888)
19.44
(4.081)
20.25
(4.584)
20.22
(3.866)
20.78
(3.420)
26.00
(4.843)
Day 7: 10 AM
21.17
(2.165)
19.11
(3.943)
18.39
(3.110)
19.15
(4.429)
20.38
(2.888)
17.44
(3.803)
25.46
(4.293)
Day 7: 1 PM
21.17
(2.525)
19.83
(3.269)
17.22
(4.063)
17.55
(3.905)
20.63
(4.224)
18.25
(4.359)
23.63
(2.909)
Day 7: 4 PM
21.17
(3.491)
20.06
(5.282)
17.61
(3.935)
16.95
(3.954)
20.88
(4.604)
18.63
(3.926)
25.58
(5.044)
Day 14: 8 AM
24.33
(4.737)
21.61
(3.927)
19.28
(2.438)
20.75
(4.906)
22.94
(3.787)
20.17
(5.750)
26.58
(4.592)
Day 14: 10 AM
20.89
(1.635)
19.78
(2.740)
18.28
(3.501)
19.90
(4.858)
21.89
(3.798)
18.06
(4.724)
24.46
(2.463)
Day 14: 1 PM
21.28
(2.078)
20.83
(2.839)
18.56
(3.754)
19.60
(5.254)
22.89
(4.029)
18.50
(3.703)
25.46
(3.665)
Day 14: 4 PM
22.78
(3.914)
21.17
(3.841)
18.78
(3.970)
19.60
(5.004)
20.67
(2.704)
19.06
(3.886)
25.08
(3.154)
6. Secondary Outcome
Title 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
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Arm/Group Title Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 9 9 9 10 9 9 12
Day0: Baseline for Day 1, 7, 14 8 AM
27.78
(1.847)
27.72
(1.693)
27.72
(2.403)
28.45
(1.471)
29.81
(2.769)
28.44
(1.887)
28.15
(2.625)
Day 0: Baseline for Day 7 10 AM
24.75
(1.916)
26.11
(2.494)
25.94
(2.872)
26.30
(1.285)
26.53
(1.906)
26.16
(2.507)
25.13
(2.519)
Day 0: Baseline for Day 7 1 PM
25.83
(3.279)
26.06
(2.965)
25.08
(2.208)
25.10
(2.289)
27.13
(3.009)
25.69
(2.191)
25.52
(2.742)
Day 0: Baseline for Day 7 4 PM
25.50
(3.403)
25.11
(3.113)
24.86
(2.405)
25.90
(2.237)
26.41
(3.068)
25.28
(1.925)
25.35
(2.907)
Day 0:Baseline for Day 14 10 AM
24.75
(1.916)
26.11
(2.494)
25.94
(2.872)
26.30
(1.285)
27.44
(3.269)
26.16
(2.507)
25.13
(2.519)
Day 0:Baseline for Day 14 1 PM
25.83
(3.279)
26.06
(2.965)
25.08
(2.208)
25.10
(2.289)
28.03
(3.906)
25.69
(2.191)
25.52
(2.742)
Day 0:Baseline for Day 14 4 PM
25.50
(3.403)
25.11
(3.113)
24.86
(2.405)
25.90
(2.237)
27.11
(3.564)
25.28
(1.925)
25.35
(2.907)
Change at Day 1 8 AM
4.89
(2.302)
5.44
(3.154)
7.72
(2.697)
6.75
(2.875)
7.75
(3.276)
7.22
(4.459)
1.35
(2.702)
Change at Day 7 8 AM
4.56
(2.957)
6.67
(1.644)
8.28
(4.186)
8.20
(3.885)
9.58
(3.356)
7.67
(4.373)
2.15
(3.224)
Change at Day 7 10 AM
3.58
(3.064)
7.00
(3.219)
7.56
(3.041)
7.15
(4.301)
6.16
(2.891)
8.72
(4.137)
-0.33
(3.099)
Change at Day 7 1 PM
4.67
(3.255)
6.22
(2.498)
7.86
(2.908)
7.55
(3.947)
6.50
(4.652)
7.44
(3.351)
1.90
(2.546)
Change at Day 7 4 PM
4.33
(2.880)
5.06
(4.083)
7.25
(2.929)
8.95
(3.787)
5.53
(4.519)
6.66
(3.744)
-0.23
(2.940)
Change at Day 14 8 AM
3.44
(3.964)
6.11
(3.518)
8.44
(2.267)
7.70
(3.994)
6.86
(2.622)
8.28
(5.701)
1.56
(2.962)
Change at Day 14 10 AM
3.86
(1.768)
6.33
(2.559)
7.67
(3.245)
6.40
(4.754)
5.56
(3.273)
8.09
(4.274)
0.67
(3.085)
Change at Day 14 1 PM
4.56
(2.524)
5.22
(2.673)
6.53
(2.746)
5.50
(4.419)
5.14
(3.664)
7.19
(2.930)
0.06
(2.794)
Change at Day 14 4 PM
2.72
(1.950)
3.94
(2.880)
6.08
(3.573)
6.30
(5.296)
6.44
(3.015)
6.22
(4.021)
0.27
(1.804)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.011
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.62
Confidence Interval (2-Sided) 90%
1.34 to 5.90
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.19
Confidence Interval (2-Sided) 90%
1.91 to 6.47
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.47
Confidence Interval (2-Sided) 90%
4.19 to 8.75
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.32
Confidence Interval (2-Sided) 90%
3.11 to 7.54
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.00
Confidence Interval (2-Sided) 90%
3.66 to 8.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.80
Confidence Interval (2-Sided) 90%
3.52 to 8.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.120
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.44
Confidence Interval (2-Sided) 90%
-0.14 to 5.02
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.005
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.55
Confidence Interval (2-Sided) 90%
1.97 to 7.14
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.17
Confidence Interval (2-Sided) 90%
3.58 to 8.75
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.03
Confidence Interval (2-Sided) 90%
3.52 to 8.54
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.31
Confidence Interval (2-Sided) 90%
4.66 to 9.95
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.50
Confidence Interval (2-Sided) 90%
2.91 to 8.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.009
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.04
Confidence Interval (2-Sided) 90%
1.56 to 6.53
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.00
Confidence Interval (2-Sided) 90%
4.49 to 9.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.61
Confidence Interval (2-Sided) 90%
5.11 to 10.11
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.08
Confidence Interval (2-Sided) 90%
4.64 to 9.53
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.01
Confidence Interval (2-Sided) 90%
3.40 to 8.62
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 8.70
Confidence Interval (2-Sided) 90%
6.11 to 11.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.066
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.66
Confidence Interval (2-Sided) 90%
0.29 to 5.02
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.006
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.13
Confidence Interval (2-Sided) 90%
1.76 to 6.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.13
Confidence Interval (2-Sided) 90%
3.76 to 8.49
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.81
Confidence Interval (2-Sided) 90%
3.51 to 8.11
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.010
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.02
Confidence Interval (2-Sided) 90%
1.53 to 6.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.48
Confidence Interval (2-Sided) 90%
3.03 to 7.93
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.006
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.55
Confidence Interval (2-Sided) 90%
1.91 to 7.19
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.30
Confidence Interval (2-Sided) 90%
2.66 to 7.94
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.51
Confidence Interval (2-Sided) 90%
4.87 to 10.16
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 9.14
Confidence Interval (2-Sided) 90%
6.57 to 11.71
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.69
Confidence Interval (2-Sided) 90%
2.94 to 8.44
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.89
Confidence Interval (2-Sided) 90%
4.16 to 9.62
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.269
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.83
Confidence Interval (2-Sided) 90%
-0.91 to 4.58
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.009
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.49
Confidence Interval (2-Sided) 90%
1.75 to 7.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.83
Confidence Interval (2-Sided) 90%
4.08 to 9.57
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.18
Confidence Interval (2-Sided) 90%
3.52 to 8.84
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.52
Confidence Interval (2-Sided) 90%
2.71 to 8.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.76
Confidence Interval (2-Sided) 90%
4.01 to 9.50
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.024
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.36
Confidence Interval (2-Sided) 90%
0.95 to 5.76
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.24
Confidence Interval (2-Sided) 90%
2.82 to 7.66
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.64
Confidence Interval (2-Sided) 90%
4.23 to 9.06
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.22
Confidence Interval (2-Sided) 90%
2.87 to 7.58
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.012
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.88
Confidence Interval (2-Sided) 90%
1.39 to 6.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.98
Confidence Interval (2-Sided) 90%
4.48 to 9.48
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag 0.005% (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.41
Confidence Interval (2-Sided) 90%
2.11 to 6.72
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.02
Confidence Interval (2-Sided) 90%
2.72 to 7.33
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 6.58
Confidence Interval (2-Sided) 90%
4.27 to 8.88
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.54
Confidence Interval (2-Sided) 90%
3.31 to 7.78
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 4.44
Confidence Interval (2-Sided) 90%
2.06 to 6.82
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 7.08
Confidence Interval (2-Sided) 90%
4.70 to 9.47
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.103
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.41
Confidence Interval (2-Sided) 90%
-0.02 to 4.84
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.013
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 3.75
Confidence Interval (2-Sided) 90%
1.32 to 6.18
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.96
Confidence Interval (2-Sided) 90%
3.53 to 8.39
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.87
Confidence Interval (2-Sided) 90%
3.50 to 8.23
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.65
Confidence Interval (2-Sided) 90%
3.18 to 8.11
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 5.97
Confidence Interval (2-Sided) 90%
3.46 to 8.48
Parameter Dispersion Type:
Value:
Estimation Comments
7. Secondary Outcome
Title Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Arm/Group Title 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)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 35 36 36 36 36 36 35
Day 1: 8 AM
19.12
(3.514)
21.91
(3.177)
20.61
(2.859)
19.39
(3.229)
18.76
(4.058)
19.69
(3.945)
20.39
(3.548)
Day 7: 8 AM
18.34
(3.115)
19.40
(3.308)
19.68
(3.140)
18.83
(2.908)
17.41
(4.035)
18.28
(3.718)
20.10
(3.698)
Day 7: 10 AM
17.26
(2.456)
18.96
(3.938)
18.61
(2.814)
17.94
(2.551)
16.80
(4.670)
17.34
(3.028)
19.10
(3.727)
Day 7: 1 PM
17.25
(3.184)
18.68
(3.122)
18.73
(3.518)
18.02
(2.872)
16.80
(4.219)
17.09
(3.057)
19.30
(3.032)
Day 7: 4 PM
17.26
(2.962)
18.67
(3.690)
18.27
(3.047)
17.65
(2.998)
16.91
(4.320)
17.56
(2.989)
19.70
(3.642)
Day 14: 8 AM
18.85
(3.439)
19.56
(3.288)
19.72
(3.644)
19.53
(3.572)
17.69
(4.580)
18.67
(4.127)
19.66
(3.908)
Day 14: 10 AM
17.81
(3.848)
19.61
(4.209)
19.44
(3.318)
18.98
(3.318)
16.66
(4.743)
17.85
(3.282)
19.40
(3.485)
Day 14: 1 PM
17.94
(3.912)
19.33
(3.619)
18.96
(3.776)
18.89
(3.219)
16.52
(4.622)
17.35
(2.612)
18.83
(3.231)
Day 14: 4 PM
17.41
(3.452)
19.35
(4.035)
18.31
(3.370)
18.66
(3.117)
16.98
(5.077)
18.26
(2.736)
19.54
(3.361)
Day 28: 8 AM
19.60
(3.794)
19.76
(3.188)
20.28
(4.294)
19.11
(3.280)
17.97
(4.876)
18.99
(3.644)
20.69
(3.577)
Day 28: 10 AM
17.93
(3.341)
19.44
(3.335)
19.74
(3.764)
18.38
(3.038)
16.86
(4.827)
17.67
(3.196)
19.64
(3.966)
Day 28: 1 PM
18.30
(3.787)
19.19
(3.092)
19.06
(3.399)
18.47
(2.396)
16.68
(5.331)
17.39
(2.680)
19.33
(3.204)
Day 28: 4 PM
17.79
(3.673)
19.08
(3.394)
19.13
(4.396)
19.06
(2.772)
17.12
(4.823)
18.56
(3.323)
20.06
(3.668)
8. Secondary Outcome
Title Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 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
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values. Here 'number analyzed' signifies participants evaluable each specified time points for each group, respectively.
Arm/Group Title 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)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 35 36 36 36 36 36 35
Day 0: Baseline for Day 1: 8AM
27.34
(1.525)
28.21
(2.349)
28.27
(2.155)
29.10
(2.714)
28.63
(2.648)
29.19
(2.962)
28.55
(2.728)
Day 0: Baseline for Day 7,14,28: 8AM
27.59
(2.098)
28.16
(2.333)
28.27
(2.155)
29.03
(2.710)
28.63
(2.648)
29.19
(2.962)
28.60
(2.656)
Day 0: Baseline for Day 7: 10AM
25.74
(3.129)
26.44
(3.005)
26.70
(2.937)
27.13
(3.453)
26.42
(2.779)
27.48
(3.450)
26.70
(3.250)
Day 0: Baseline for Day 7: 1PM
24.85
(2.501)
25.67
(2.754)
26.19
(2.992)
26.04
(3.179)
25.34
(2.707)
26.27
(3.335)
25.99
(2.863)
Day 0: Baseline for Day 7: 4PM
24.83
(2.901)
25.59
(3.040)
25.87
(3.054)
25.92
(3.293)
25.35
(3.117)
26.12
(3.154)
25.84
(3.243)
Day 0: Baseline for Day 14: 10AM
25.70
(3.089)
26.44
(3.005)
26.66
(2.854)
26.94
(3.449)
26.42
(2.779)
27.41
(3.423)
26.70
(3.250)
Day 0: Baseline for Day 14: 1PM
24.84
(2.466)
25.67
(2.754)
26.13
(2.949)
25.92
(3.068)
25.34
(2.707)
26.21
(3.297)
25.99
(2.863)
Day 0: Baseline for Day 14: 4PM
24.87
(2.868)
25.59
(3.040)
25.86
(3.013)
25.99
(3.206)
25.35
(3.117)
26.20
(3.145)
25.84
(3.243)
Day 0: Baseline for Day 28: 10AM
25.70
(3.089)
26.44
(3.005)
26.66
(2.854)
27.06
(3.467)
26.42
(2.779)
27.41
(3.423)
26.70
(3.250)
Day 0: Baseline for Day 28: 1PM
24.84
(2.466)
25.67
(2.754)
26.13
(2.949)
25.98
(3.042)
25.34
(2.707)
26.21
(3.297)
25.99
(2.863)
Day 0: Baseline for Day 28: 4PM
24.87
(2.868)
25.59
(3.040)
25.86
(3.013)
26.00
(3.156)
25.35
(3.117)
26.20
(3.145)
25.84
(3.243)
Change at Day 1: 8AM
8.22
(4.071)
6.29
(3.117)
7.66
(3.110)
9.72
(3.484)
9.87
(2.786)
9.49
(4.242)
8.16
(4.031)
Change at Day 7: 8AM
9.24
(3.987)
8.76
(3.459)
8.59
(3.317)
10.20
(3.497)
11.22
(3.393)
10.91
(3.623)
8.50
(3.343)
Change at Day 7: 10AM
8.47
(3.754)
7.49
(3.057)
8.10
(3.328)
9.19
(3.646)
9.61
(3.448)
10.14
(2.935)
7.60
(3.031)
Change at Day 7: 1PM
7.60
(3.499)
6.99
(2.943)
7.46
(3.576)
8.02
(4.046)
8.54
(3.043)
9.17
(4.022)
6.69
(2.996)
Change at Day 7: 4PM
7.57
(3.525)
6.92
(3.552)
7.60
(3.388)
8.27
(3.161)
8.44
(2.888)
8.55
(3.081)
6.14
(3.011)
Change at Day 14: 8AM
8.74
(3.829)
8.60
(3.254)
8.55
(3.473)
9.50
(3.915)
10.94
(3.793)
10.52
(4.446)
8.94
(3.462)
Change at Day 14: 10AM
7.89
(4.568)
6.83
(3.151)
7.22
(3.292)
7.95
(3.900)
9.76
(3.467)
9.56
(3.121)
7.30
(2.397)
Change at Day 14: 1PM
6.89
(4.225)
6.33
(2.837)
7.17
(3.502)
7.03
(3.710)
8.83
(3.364)
8.86
(3.710)
7.16
(3.229)
Change at Day 14: 4PM
7.46
(3.725)
6.24
(3.510)
7.55
(3.392)
7.33
(3.649)
8.36
(3.721)
7.95
(3.045)
6.30
(3.746)
Change at Day 28: 8AM
7.99
(4.108)
8.40
(3.501)
8.00
(3.851)
9.92
(3.845)
10.66
(3.741)
10.20
(3.958)
7.91
(2.802)
Change at Day 28: 10AM
7.78
(3.987)
7.00
(3.383)
6.92
(3.706)
8.68
(4.674)
9.55
(3.561)
9.74
(3.743)
7.06
(3.311)
Change at Day 28: 1PM
6.54
(3.965)
6.47
(2.645)
7.07
(3.472)
7.51
(3.915)
8.66
(4.073)
8.82
(4.037)
6.66
(2.804)
Change at Day 28: 4PM
7.09
(3.938)
6.51
(3.302)
6.74
(4.480)
6.94
(3.962)
8.23
(3.420)
7.64
(3.762)
5.79
(3.219)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.377
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.72
Confidence Interval (2-Sided) 90%
-0.63 to 2.08
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.039
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -1.68
Confidence Interval (2-Sided) 90%
-3.01 to -0.35
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.668
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.34
Confidence Interval (2-Sided) 90%
-1.67 to 0.98
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.121
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.26
Confidence Interval (2-Sided) 90%
-0.07 to 2.59
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.039
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.67
Confidence Interval (2-Sided) 90%
0.34 to 2.99
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.220
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.99
Confidence Interval (2-Sided) 90%
-0.34 to 2.31
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.098
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.30
Confidence Interval (2-Sided) 90%
0.01 to 2.59
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.519
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.50
Confidence Interval (2-Sided) 90%
-0.77 to 1.77
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.724
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.27
Confidence Interval (2-Sided) 90%
-1.00 to 1.55
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.059
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.46
Confidence Interval (2-Sided) 90%
0.19 to 2.74
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.71
Confidence Interval (2-Sided) 90%
1.43 to 3.98
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.008
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.09
Confidence Interval (2-Sided) 90%
0.82 to 3.37
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.068
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.32
Confidence Interval (2-Sided) 90%
0.13 to 2.51
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.994
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.01
Confidence Interval (2-Sided) 90%
-1.16 to 1.18
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.494
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.50
Confidence Interval (2-Sided) 90%
-0.70 to 1.69
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.063
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.39
Confidence Interval (2-Sided) 90%
0.16 to 2.62
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.15
Confidence Interval (2-Sided) 90%
0.95 to 3.34
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.17
Confidence Interval (2-Sided) 90%
0.97 to 3.38
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 19
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.038
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.55
Confidence Interval (2-Sided) 90%
0.32 to 2.77
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 20
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.512
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.48
Confidence Interval (2-Sided) 90%
-0.72 to 1.68
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 21
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.373
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.66
Confidence Interval (2-Sided) 90%
-0.56 to 1.89
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 22
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.088
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.31
Confidence Interval (2-Sided) 90%
0.05 to 2.56
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 23
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.21
Confidence Interval (2-Sided) 90%
0.98 to 3.44
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 24
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.003
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.33
Confidence Interval (2-Sided) 90%
1.09 to 3.57
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 25
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.010
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS Mean Difference
Estimated Value 1.87
Confidence Interval (2-Sided) 90%
0.69 to 3.04
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 26
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.205
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.89
Confidence Interval (2-Sided) 90%
-0.27 to 2.05
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 27
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.045
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.44
Confidence Interval (2-Sided) 90%
0.26 to 2.63
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 28
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.005
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.09
Confidence Interval (2-Sided) 90%
0.88 to 3.31
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 29
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.51
Confidence Interval (2-Sided) 90%
1.33 to 3.70
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 30
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.29
Confidence Interval (2-Sided) 90%
1.10 to 3.48
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 31
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.757
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.27
Confidence Interval (2-Sided) 90%
-1.15 to 1.69
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 32
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.878
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.13
Confidence Interval (2-Sided) 90%
-1.54 to 1.27
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 33
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.780
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.24
Confidence Interval (2-Sided) 90%
-1.64 to 1.17
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 34
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.670
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.36
Confidence Interval (2-Sided) 90%
-1.04 to 1.77
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 35
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.021
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.98
Confidence Interval (2-Sided) 90%
0.58 to 3.38
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 36
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.126
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.31
Confidence Interval (2-Sided) 90%
-0.10 to 2.71
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 37
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.215
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
-0.32 to 2.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 38
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.635
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.37
Confidence Interval (2-Sided) 90%
-1.65 to 0.91
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 39
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.934
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.06
Confidence Interval (2-Sided) 90%
-1.35 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 40
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.478
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.56
Confidence Interval (2-Sided) 90%
-0.74 to 1.87
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 41
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.57
Confidence Interval (2-Sided) 90%
1.26 to 3.87
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 42
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.013
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.99
Confidence Interval (2-Sided) 90%
0.68 to 3.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 43
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.736
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.27
Confidence Interval (2-Sided) 90%
-1.04 to 1.57
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 44
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.386
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.68
Confidence Interval (2-Sided) 90%
-1.96 to 0.61
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 45
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.948
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.05
Confidence Interval (2-Sided) 90%
-1.35 to 1.24
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 46
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.908
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.09
Confidence Interval (2-Sided) 90%
-1.41 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 47
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.015
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.97
Confidence Interval (2-Sided) 90%
0.65 to 3.28
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 48
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.046
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.60
Confidence Interval (2-Sided) 90%
0.29 to 2.92
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 49
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.042
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.60
Confidence Interval (2-Sided) 90%
0.31 to 2.89
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 50
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.940
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.06
Confidence Interval (2-Sided) 90%
-1.22 to 1.34
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 51
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.114
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.24
Confidence Interval (2-Sided) 90%
-0.05 to 2.53
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 52
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.228
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.97
Confidence Interval (2-Sided) 90%
-0.35 to 2.28
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 53
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.005
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.29
Confidence Interval (2-Sided) 90%
0.98 to 3.60
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 54
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.063
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.48
Confidence Interval (2-Sided) 90%
0.17 to 2.79
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 55
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.562
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.50
Confidence Interval (2-Sided) 90%
-0.92 to 1.91
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 56
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.431
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.67
Confidence Interval (2-Sided) 90%
-0.73 to 2.07
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 57
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.795
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.22
Confidence Interval (2-Sided) 90%
-1.18 to 1.62
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 58
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.032
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.83
Confidence Interval (2-Sided) 90%
0.43 to 3.23
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 59
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.73
Confidence Interval (2-Sided) 90%
1.34 to 4.13
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 60
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.017
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.04
Confidence Interval (2-Sided) 90%
0.64 to 3.44
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 61
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.124
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.26
Confidence Interval (2-Sided) 90%
-0.09 to 2.60
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 62
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.920
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.08
Confidence Interval (2-Sided) 90%
-1.25 to 1.41
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 63
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.887
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.12
Confidence Interval (2-Sided) 90%
-1.46 to 1.22
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 64
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.083
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.42
Confidence Interval (2-Sided) 90%
0.08 to 2.77
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 65
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.65
Confidence Interval (2-Sided) 90%
1.29 to 4.01
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 66
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.006
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.30
Confidence Interval (2-Sided) 90%
0.94 to 3.66
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 67
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.533
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.49
Confidence Interval (2-Sided) 90%
-0.80 to 1.78
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 68
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.985
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -0.02
Confidence Interval (2-Sided) 90%
-1.29 to 1.26
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 69
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.665
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.34
Confidence Interval (2-Sided) 90%
-0.95 to 1.62
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 70
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.276
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.86
Confidence Interval (2-Sided) 90%
-0.44 to 2.15
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 71
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.004
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.34
Confidence Interval (2-Sided) 90%
1.04 to 3.65
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 72
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.011
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.04
Confidence Interval (2-Sided) 90%
0.74 to 3.35
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 73
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.0025% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.033
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.78
Confidence Interval (2-Sided) 90%
0.41 to 3.14
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 74
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.005% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.302
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.84
Confidence Interval (2-Sided) 90%
-0.50 to 2.19
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 75
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.01% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.255
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 0.94
Confidence Interval (2-Sided) 90%
-0.42 to 2.30
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 76
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.015% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.198
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.08
Confidence Interval (2-Sided) 90%
-0.30 to 2.46
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 77
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.02% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.002
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 2.68
Confidence Interval (2-Sided) 90%
1.30 to 4.06
Parameter Dispersion Type:
Value:
Estimation Comments
Statistical Analysis 78
Statistical Analysis Overview Comparison Group Selection Taprenepag 0.03% (Stage I), Taprenepag Vehicle (Stage I)
Comments 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.
Type of Statistical Test Superiority or Other (legacy)
Comments
Statistical Test of Hypothesis p-Value 0.046
Comments
Method ANCOVA
Comments
Method of Estimation Estimation Parameter LS mean difference
Estimated Value 1.68
Confidence Interval (2-Sided) 90%
0.30 to 3.06
Parameter Dispersion Type:
Value:
Estimation Comments
9. Secondary Outcome
Title Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
Arm/Group Title Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 9 9 9 10 9 9 12
Number [percentage of participants]
0.0
0%
11.1
123.3%
11.1
123.3%
0.0
0%
11.1
123.3%
22.2
246.7%
0.0
0%
10. Secondary Outcome
Title Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Description 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

Outcome Measure Data

Analysis Population Description
ITT population included all randomized participants who received at least 1 dose of study medication. LOCF method was used to impute missing values.
Arm/Group Title 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)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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.
Measure Participants 35 36 36 36 36 36 35
Number [percentage of participants]
22.9
254.4%
2.8
31.1%
13.9
154.4%
8.3
83%
38.9
432.2%
16.7
185.6%
5.7
47.5%

Adverse Events

Time Frame
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.
Arm/Group Title Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I) Latanoprost Vehicle and Taprenepag 0.005% (Stage II) Latanoprost Vehicle and Taprenepag 0.01% (Stage II) Latanoprost Vehicle and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag 0.005% (Stage II) Latanoprost 0.005% and Taprenepag 0.01% (Stage II) Latanoprost 0.005% and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Arm/Group Description 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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.
All Cause Mortality
Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I) Latanoprost Vehicle and Taprenepag 0.005% (Stage II) Latanoprost Vehicle and Taprenepag 0.01% (Stage II) Latanoprost Vehicle and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag 0.005% (Stage II) Latanoprost 0.005% and Taprenepag 0.01% (Stage II) Latanoprost 0.005% and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I) Latanoprost Vehicle and Taprenepag 0.005% (Stage II) Latanoprost Vehicle and Taprenepag 0.01% (Stage II) Latanoprost Vehicle and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag 0.005% (Stage II) Latanoprost 0.005% and Taprenepag 0.01% (Stage II) Latanoprost 0.005% and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 2/36 (5.6%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Cardiac disorders
Myocardial infarction 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Tachycardia 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Ear and labyrinth disorders
Vertigo 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Gastrointestinal disorders
Diverticulum 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Other (Not Including Serious) Adverse Events
Taprenepag 0.0025% (Stage I) Taprenepag 0.005% (Stage I) Taprenepag 0.01% (Stage I) Taprenepag 0.015% (Stage I) Taprenepag 0.02% (Stage I) Taprenepag 0.03% (Stage I) Taprenepag Vehicle (Stage I) Latanoprost Vehicle and Taprenepag 0.005% (Stage II) Latanoprost Vehicle and Taprenepag 0.01% (Stage II) Latanoprost Vehicle and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag 0.005% (Stage II) Latanoprost 0.005% and Taprenepag 0.01% (Stage II) Latanoprost 0.005% and Taprenepag 0.015% (Stage II) Latanoprost 0.005% and Taprenepag Vehicle (Stage II)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 3/9 (33.3%) 3/9 (33.3%) 0/9 (0%) 5/10 (50%) 5/9 (55.6%) 9/9 (100%) 4/12 (33.3%) 18/35 (51.4%) 20/36 (55.6%) 27/36 (75%) 24/36 (66.7%) 27/36 (75%) 26/36 (72.2%) 15/35 (42.9%)
Ear and labyrinth disorders
Ear discomfort 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Eye disorders
Abnormal sensation in eye, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 2/9 (22.2%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Abnormal sensation in eye, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/9 (11.1%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Asthenopia, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Blepharitis, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Cataract nuclear, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Chalazion, LEFT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 1/12 (8.3%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Chorioretinopathy, RIGHT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Conjunctival haemorrhage, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Conjunctival haemorrhage, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Conjunctival hyperaemia, BOTH EYES 1/9 (11.1%) 2/9 (22.2%) 0/9 (0%) 1/10 (10%) 0/9 (0%) 5/9 (55.6%) 3/12 (25%) 10/35 (28.6%) 10/36 (27.8%) 11/36 (30.6%) 13/36 (36.1%) 13/36 (36.1%) 13/36 (36.1%) 9/35 (25.7%)
Conjunctival hyperaemia, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/9 (11.1%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Conjunctival hyperaemia, LEFT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Conjunctival hyperaemia, RIGHT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 2/36 (5.6%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Conjunctival hyperaemia, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/9 (11.1%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Conjunctivitis, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Corneal disorder, BOTH EYES 0/9 (0%) 1/9 (11.1%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11.1%) 0/12 (0%) 0/35 (0%) 2/36 (5.6%) 1/36 (2.8%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Corneal erosion, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 2/36 (5.6%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 1/35 (2.9%)
Corneal erosion, LEFT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Corneal erosion, RIGHT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Corneal oedema, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 2/36 (5.6%) 0/35 (0%)
Dry eye, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 1/36 (2.8%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 1/36 (2.8%) 0/35 (0%)
Erythema of eyelid, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Extraocular muscle disorder, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Eye discharge, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Eye inflammation, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Eye irritation, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 2/35 (5.7%) 2/36 (5.6%) 1/36 (2.8%) 3/36 (8.3%) 5/36 (13.9%) 3/36 (8.3%) 5/35 (14.3%)
Eye pain, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/10 (10%) 0/9 (0%) 1/9 (11.1%) 0/12 (0%) 0/35 (0%) 3/36 (8.3%) 3/36 (8.3%) 3/36 (8.3%) 3/36 (8.3%) 6/36 (16.7%) 1/35 (2.9%)
Eye pain, LEFT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/10 (10%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Eye pain, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Eye pruritus, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11.1%) 0/12 (0%) 1/35 (2.9%) 2/36 (5.6%) 3/36 (8.3%) 3/36 (8.3%) 2/36 (5.6%) 2/36 (5.6%) 1/35 (2.9%)
Eyelid oedema, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Eyelids pruritus, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Foreign body sensation in eyes, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/9 (11.1%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Foreign body sensation in eyes, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Foreign body sensation in eyes, RIGHT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Hypermetropia, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Iritis, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/9 (11.1%) 2/9 (22.2%) 0/12 (0%) 1/35 (2.9%) 2/36 (5.6%) 3/36 (8.3%) 1/36 (2.8%) 1/36 (2.8%) 4/36 (11.1%) 0/35 (0%)
Iritis, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11.1%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 1/35 (2.9%)
Iritis, LEFT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Iritis, RIGHT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 1/35 (2.9%)
Iritis, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11.1%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 1/36 (2.8%) 1/35 (2.9%)
Lacrimation increased, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 2/36 (5.6%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Macular oedema, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Myodesopsia, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Myopia, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Ocular discomfort, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Ocular hyperaemia, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/10 (10%) 1/9 (11.1%) 1/9 (11.1%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Ocular hyperaemia, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Ocular hyperaemia, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Open angle glaucoma, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Photophobia, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 1/10 (10%) 3/9 (33.3%) 4/9 (44.4%) 0/12 (0%) 5/35 (14.3%) 5/36 (13.9%) 12/36 (33.3%) 7/36 (19.4%) 7/36 (19.4%) 15/36 (41.7%) 1/35 (2.9%)
Photophobia, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 1/9 (11.1%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Vision blurred, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/9 (11.1%) 1/9 (11.1%) 0/12 (0%) 2/35 (5.7%) 3/36 (8.3%) 4/36 (11.1%) 5/36 (13.9%) 1/36 (2.8%) 3/36 (8.3%) 0/35 (0%)
Vision blurred, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Vision blurred, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Visual acuity reduced, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 2/36 (5.6%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Visual acuity reduced, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 2/36 (5.6%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Visual acuity reduced, LEFT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/35 (2.9%)
Visual acuity reduced, RIGHT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 2/36 (5.6%) 0/35 (0%)
Gastrointestinal disorders
Abdominal pain upper 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
General disorders
Fatigue 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Instillation site irritation, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 2/36 (5.6%) 0/36 (0%) 1/35 (2.9%)
Instillation site pain, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Sensation of foreign body, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/35 (2.9%)
Infections and infestations
Bronchitis 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Conjunctivitis viral, RIGHT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Nasopharyngitis 2/9 (22.2%) 1/9 (11.1%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 1/12 (8.3%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Oral herpes 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Sinusitis bacterial 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Upper respiratory tract infection 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 2/36 (5.6%) 0/36 (0%) 0/36 (0%) 1/35 (2.9%)
Urinary tract infection 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Investigations
Blood glucose increased 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Corneal staining, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 1/35 (2.9%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/35 (0%)
Corneal staining, LEFT EYE, FELLOW EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Corneal staining, RIGHT EYE, STUDY EYE 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Nervous system disorders
Headache 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 1/36 (2.8%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Headache, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Migraine, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/35 (0%)
Visual field defect, BOTH EYES 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Renal and urinary disorders
Haematuria 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Reproductive system and breast disorders
Breast mass 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)
Skin and subcutaneous tissue disorders
Swelling face 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 1/9 (11.1%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/35 (0%)
Vascular disorders
Hypertension 0/9 (0%) 0/9 (0%) 0/9 (0%) 0/10 (0%) 0/9 (0%) 0/9 (0%) 0/12 (0%) 0/35 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 0/36 (0%) 1/36 (2.8%) 0/35 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Results Point of Contact

Name/Title Pfizer ClinicalTrials.gov Call Center
Organization Pfizer, Inc.
Phone 1-800-718-1021
Email ClinicalTrials.gov_Inquiries@pfizer.com
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT00572455
Other Study ID Numbers:
  • A0191001
First Posted:
Dec 13, 2007
Last Update Posted:
Apr 30, 2021
Last Verified:
Apr 1, 2021