Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma
- Conditions
- Primary Open Angle GlaucomaOcular HypertensionPigmentary GlaucomaPseudoexfoliative Glaucoma
- Interventions
- Registration Number
- NCT00441883
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
This study will evaluate the safety and efficacy of PF 03187207.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 176
-Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes
-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PF-03187207 and Latanoprost Vehicle PF-03187207 and Latanoprost Vehicle One drop of each, once daily in study eye for 28 days Latanoprost 0.005% and PF-03187207 Vehicle Latanoprost 0.005% and PF-03187207 Vehicle One drop of each, once daily in study eye for 28 days
- Primary Outcome Measures
Name Time Method Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 Baseline, 28 days Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Diurnal IOP, defined as the mean IOP over the day based on values obtained at 8 AM, 10 AM, 1 PM, and 4 PM, was calculated for each visit. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Mean Intraocular Pressure IOP at the Day 7, 14, and 21 Visits Baseline, Day 7, Day 14, and Day 21 Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. gBoth eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg at Any Visit Through Day 28 28 days Intraocular pressure (IOP) was measured using a Goldmann applanation tonometer. Both eyes were tested, with the right eye preceding the left eye. The operator initially set the dial at 10 mmHg, then looked through the slit lamp and adjusted the dial to take the reading, and then recorded the results. The procedure was repeated on the same eye twice consecutively. If the measurements were within 2 mmHg or less of each other, the mean of the 2 readings was recorded as the IOP at that time point. If the 2 readings were more than 2 mmHg of each other, a third (consecutive) reading was taken and the median (middle) IOP was recorded as the IOP at that time point.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇸Austin, Texas, United States