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

Bausch & Lomb Incorporated117 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

117

Conditions

Primary Open Angle Glaucoma Ocular Hypertension

Interventions

PF-03187207DRUG

Latanoprost 0.005%DRUG

PF-03187207 VehicleDRUG

One drop in study eye once daily for the first 28 days to all subjects, followed by 28 days in combination with PF-03187207.

Latanoprost Vehicle

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (13)

Pfizer Investigational Site

Narashino, Chiba, Japan

Pfizer Investigational Site

Shimachi, Chiba, Japan

Pfizer Investigational Site

Kawasaki, Kanagawa, Japan

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 28 days

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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