A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.
- Conditions
- Primary Open Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT00595101
- Lead Sponsor
- Bausch & Lomb Incorporated
- Brief Summary
To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 117
- Man or woman at least 20 years of age
- Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes.
- Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- Contraindications to latanoprost and nitric oxide treatment
- Known latanoprost non-responders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Latanoprost 0.005% and PF-03187207 Vehicle Latanoprost 0.005% A single drop of each, once daily in study eye for 28 days Latanoprost 0.005% and PF-03187207 Vehicle PF-03187207 Vehicle A single drop of each, once daily in study eye for 28 days PF-03187207 Medium Dose and Latanoprost Vehicle Latanoprost Vehicle A single drop of each, once daily in study eye for 28 days PF-03187207 Low Dose and Latanoprost Vehicle Latanoprost Vehicle A single drop of each, once daily in study eye for 28 days PF-03187207 High Dose and Latanoprost Vehicle Latanoprost Vehicle A single drop of each, once daily in study eye for 28 days PF-03187207 High Dose and Latanoprost Vehicle PF-03187207 A single drop of each, once daily in study eye for 28 days PF-03187207 Medium Dose and Latanoprost Vehicle PF-03187207 A single drop of each, once daily in study eye for 28 days PF-03187207 Low Dose and Latanoprost Vehicle PF-03187207 A single 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 Specific Time Points on Day 14 and Day 28 Baseline, Day 14, Day 28 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.
Target IOP Up to 28 days Percentage of participants with IOP of 18 mmHg or Lower, 16 mmHg or Lower, or 14 mmHg or Lower at Any Visit Through Day 28. 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
🇯🇵Shizuoka, Japan