A Phase 2, Dose Finding Study of PF-03187207 in Patients With Primary Open Angle Glaucoma or Ocular Hypertension.

Study Overview
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Brief Summary
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To investigate dose response, safety and efficacy of PF-03187207 in patients with primary open-angle glaucoma or ocular hypertension

Official Title
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A Phase 2, 28-Day Parallel-Group, Double-Masked, Dose Finding Study Comparing The Safety And Efficacy Of PF-03187207 To Latanoprost In Patients With Primary Open Angle Glaucoma Or Ocular Hypertension.

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: PF-03187207
* Drug: Latanoprost 0.005%
* Drug: PF-03187207 Vehicle
* Drug: Latanoprost Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or woman at least 20 years of age Diagnosis of primary open-angle glaucoma or ocular hypertension in one or both eyes. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-03187207 High Dose and Latanoprost Vehicle<br>A single drop of each, once daily in study eye for 28 days | Drug: PF-03187207<br> <br> Drug: Latanoprost Vehicle<br> <br> |
| Experimental: Latanoprost 0.005% and PF-03187207 Vehicle<br>A single drop of each, once daily in study eye for 28 days | Drug: Latanoprost 0.005%<br> <br> Drug: PF-03187207 Vehicle<br>* One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.<br>|
| Experimental: PF-03187207 Medium Dose and Latanoprost Vehicle<br>A single drop of each, once daily in study eye for 28 days | Drug: PF-03187207<br> <br> Drug: Latanoprost Vehicle<br> <br> |
| Experimental: PF-03187207 Low Dose and Latanoprost Vehicle<br>A single drop of each, once daily in study eye for 28 days | Drug: PF-03187207<br> <br> Drug: Latanoprost Vehicle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline Mean Diurnal Intraocular Pressure (IOP) in the Study Eye on Day 28 | 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. | Baseline, 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Intraocular Pressure (IOP) at Specific Time Points on Day 14 and 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. | Baseline, Day 14, Day 28 | 
| Target IOP | 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. | Up to 28 days |