To evaluate the safety and efficacy of PF-04217329.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
318
1 drop of lowest dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
Sall Research Medical Center
Artesia, California, United States
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 14: Stage I
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 millimeter of mercury (mmHg), the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 14.
Time frame: Stage I: Baseline, Day 14
Change From Baseline in Mean Diurnal Intra Ocular Pressure (IOP) in Study Eye at Day 28: Stage II
Diurnal IOP was defined as the mean IOP over 24 hours. IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = diurnal IOP at baseline - diurnal IOP at Day 28.
Time frame: Stage II: Baseline, Day 28
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage I
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
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1 drop of high middle dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of highest dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Five minutes after latanoprost vehicle, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Five minutes after latanoprost vehicle, 1 drop of middle dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of latanoprost vehicle, once a day, per dosed eye for duration of study.
Five minutes after latanoprost vehicle, 1 drop of high dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Five minutes after latanoprost 0.005%, 1 drop of low dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Five minutes after latanoprost 0.005%, 1 drop middle dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Five minutes after latanoprost 0.005%, 1 drop high dose PF-04217329, once a day, per dosed eye for duration of study.
1 drop of latanoprost 0.005%, once a day, per dosed eye for duration of study.
Five minutes after latanoprost 0.005%, 1 drop of PF-04217329 vehicle, once a day, per dosed eye for duration of study.
Eye Research Foundation
Newport Beach, California, United States
North Bay Eye Associates, Inc.
Petaluma, California, United States
Centre For Health Care
Poway, California, United States
Atlantic Institute of Clinical Research
Daytona Beach, Florida, United States
Florida Health Care Plans
Daytona Beach, Florida, United States
Eye Associates of Fort Myers
Fort Myers, Florida, United States
International Eye Associates, PA
Ormond Beach, Florida, United States
Coastal Research Associates,LLC
Atlanta, Georgia, United States
Omni Eye Services of Atlanta
Atlanta, Georgia, United States
...and 13 more locations
Time frame: Stage I: Day 1 up to 28 days after last dose of study medication (up to 44 days)
Number of Participants With Treatment Emergent Ocular Adverse Events (AEs): Stage II
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. Ocular AEs were the events which were localized in the ocular region.
Time frame: Stage II: Day 1 up to 28 days after last dose of study medication (up to 59 days)
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Time frame: Stage I: 8 ante meridiem (AM) on Day 1, 8 AM, 10 AM, 1 post meridiem (PM), 4 PM on Day 7, and 14
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 and 14 (8 AM, 10 AM, 1 PM, 4 PM): Stage I
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7 and 14).
Time frame: Stage I: 8 AM, 10 AM, 1 PM, 4 PM on Day 0 (Baseline), 8 AM on Day 1, 8 AM, 10 AM, 1 PM, 4 PM on Day 7, and 14
Mean Intra Ocular Pressure (IOP) in Study Eye: Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both the eyes, and the eye with higher IOP reading at the 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both the measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values.
Time frame: Stage II: 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 PM, 4 PM), 14 (8 AM, 10 AM, 1 PM, 4 PM) and Day 28 (8 AM, 10 AM, 1 PM, 4 PM): Stage II
IOP was measured using Goldmann applanation tonometer. IOP was measured in both eyes, and the eye with higher IOP reading at 2 eligibility visits was referred as 'study eye' for efficacy assessment. If both measurements were equal, right eye was selected as the study eye. IOP was measured twice in the same eye, and if the difference between 2 measurements was less than or equal to 2 mmHg, the mean of the 2 readings was recorded as the IOP at that time point. If the difference between 2 readings was greater than 2 mmHg, a third consecutive reading was taken and the median IOP was recorded as the IOP at that time point. Mean IOP was reported as the average of individual participants' mean or median IOP values. Change from baseline = baseline IOP - post-baseline IOP. Change at various post-dose time points was calculated from the baseline values at same time points on Day 0 (for example, value at 8 AM on Day 0 was used as baseline value for 8 AM value on Day 1, 7, 14 and 28).
Time frame: Stage II: 8 AM, 10 AM, 1 PM, and 4 PM on Day 0 (Baseline), 8 AM on Day 1; 8 AM, 10 AM, 1 PM, 4 PM on Days 7, 14, and 28
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage I
Percentage of participants who reached an IOP of less than or equal to (\<=) 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage I were reported. IOP was measured using Goldmann applanation tonometer.
Time frame: Stage I: Day 1 up to Day 14
Percentage of Participants Reaching and Maintaining Target Intra Ocular Pressure (IOP): Stage II
Percentage of participants who reached an IOP \<= 18 mmHg by post-eligibility visit (Day 1) and maintained an IOP \<= 18 mm Hg across all post-eligibility visits in Stage II were reported. IOP was measured using Goldmann applanation tonometer.
Time frame: Stage II: Day 1 up to Day 28