Safety and Efficacy of PF-04217329 in Patients With Glaucoma or Elevated Eye Pressure.
- Conditions
- Ocular HypertensionPrimary Open-Angle Glaucoma
- Interventions
- Drug: Latanoprost VehicleDrug: PF-04217329 - Middle DoseDrug: PF-4217329 - Highest DoseDrug: PF-04217329 - Lowest DoseDrug: PF-04217329 - Low DoseDrug: Latanoprost 0.005%Drug: PF-04217329 - High Middle DoseDrug: PF-04217329 - High DoseDrug: PF-04217329 - Vehicle
- Registration Number
- NCT00572455
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the safety and efficacy of PF-04217329.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 318
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle Latanoprost Vehicle - Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle Latanoprost Vehicle - Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle Latanoprost Vehicle - Stage 2: PF-04217329 - High Dose + Latanoprost Vehicle PF-04217329 - High Dose - Stage 1: PF-04217329 - Middle Dose PF-04217329 - Middle Dose - Stage 1: PF-02417329 - Highest Dose PF-4217329 - Highest Dose - Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005% PF-04217329 - Middle Dose - Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005% PF-04217329 - Vehicle - Stage 1: PF-04217329 - Lowest Dose PF-04217329 - Lowest Dose - Stage 1: PF-04217329 - Low Dose PF-04217329 - Low Dose - Stage 1: PF-04217329 - Vehicle PF-04217329 - Vehicle - Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005% Latanoprost 0.005% - Stage 1: PF-04217329 - High Middle Dose PF-04217329 - High Middle Dose - Stage 1: PF-04217329 - High Dose PF-04217329 - High Dose - Stage 2: PF-04217329 - Low Dose + Latanoprost Vehicle PF-04217329 - Low Dose - Stage 2: PF-04217329 - Middle Dose + Latanoprost Vehicle PF-04217329 - Middle Dose - Stage 2: PF-04217329 - High Dose + Latanoprost 0.005% PF-04217329 - High Dose - Stage 2: PF-04217329 - Low Dose + Latanoprost 0.005% PF-04217329 - Low Dose - Stage 2: PF-04217329 - Middle Dose + Latanoprost 0.005% Latanoprost 0.005% - Stage 2: PF-04217329 - High Dose + Latanoprost 0.005% Latanoprost 0.005% - Stage 2: PF-04217329 - Vehicle + Latanoprost 0.005% Latanoprost 0.005% -
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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).
Change From Baseline in Mean Intra Ocular Pressure (IOP) in Study Eye at Day 1 (8 AM), 7 (8 AM, 10 AM, 1 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.
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.
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.
Trial Locations
- Locations (23)
Eye Research Foundation
🇺🇸Newport Beach, California, United States
Sall Research Medical Center
🇺🇸Artesia, 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
Omni Eye Services of Atlanta
🇺🇸Atlanta, Georgia, United States
Coastal Research Associates,LLC
🇺🇸Atlanta, Georgia, United States
Eye Care Centers Management, Inc.
🇺🇸Morrow, Georgia, United States
The Eye Group of Southern Indiana
🇺🇸Evansville, Indiana, United States
Rochester Ophthalmological Group, PC
🇺🇸Rochester, New York, United States
Taustine Eye Center
🇺🇸Louisville, Kentucky, United States
Charlotte Eye Ear Nose and Throat Associates, PA
🇺🇸Charlotte, North Carolina, United States
Cornerstone Eye Care
🇺🇸High Point, North Carolina, United States
Mark J. Weiss, MD. Inc.
🇺🇸Tulsa, Oklahoma, United States
Glaucoma Care Center at Century Eye Care
🇺🇸Bristol, Pennsylvania, United States
Wills Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Texan Eye Care, PA
🇺🇸Austin, Texas, United States
Eye Physicians of Austin
🇺🇸Austin, Texas, United States
Total Eye Care, PA
🇺🇸Memphis, Tennessee, United States
Bluestein Custom Vision
🇺🇸Charleston, South Carolina, United States