Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
Study Details
Study Description
Brief Summary
To evaluate the safety and efficacy of PF-04217329.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Study Design
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
- Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I [Stage I: Baseline, Day 14]
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
- Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II [Stage II: Baseline, Day 28]
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
- Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I [Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)]
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
- Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II [Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)]
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Secondary Outcome Measures
- Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I [Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14]
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
- Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I [Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14]
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
- Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II [Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28]
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
- Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II [Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28]
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
- Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I [Stage I: Day 1 up to Day 14]
Percentage of participants who reached an IOP of less than or equal to (<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
- Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II [Stage II: Day 1 up to Day 28]
Percentage of participants who reached an IOP <= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP <= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.
Eligibility Criteria
Criteria
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.- A0191001
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
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 |
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 |
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%
|
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%
|
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)
|
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 |
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)
|
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 |
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%
|
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 |
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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 |
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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 |
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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
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 |
ClinicalTrials.gov_Inquiries@pfizer.com |
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