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

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.

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

Study Overview

• Status: Completed
• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Intervention / Treatment: Drug: Latanoprost 0.005%; Drug: PF-03187207; Drug: Latanoprost Vehicle; Drug: PF-03187207 Vehicle

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Shizuoka, Japan
    • Pfizer Investigational Site
  • Chiba
    • Narashino, Chiba, Japan
      • Pfizer Investigational Site
    • Shimachi, Chiba, Japan
      • Pfizer Investigational Site
  • Kanagawa
    • Kawasaki, Kanagawa, Japan
      • Pfizer Investigational Site
  • Saitama
    • Kasukabe, Saitama, Japan
      • Pfizer Investigational Site
  • Shizuoka
    • Fuji, Shizuoka, Japan
      • Pfizer Investigational Site
    • Mishima, Shizuoka, Japan
      • Pfizer Investigational Site
    • Susono, Shizuoka, Japan
      • Pfizer Investigational Site
  • Tokyo
    • Hachioji, Tokyo, Japan
      • Pfizer Investigational Site
    • Hamura, Tokyo, Japan
      • Pfizer Investigational Site
    • Minato, Tokyo, Japan
      • Pfizer Investigational Site
    • Musashino, Tokyo, Japan
      • Pfizer Investigational Site
    • Setagaya, Tokyo, Japan
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Investigators: Study Director: Ken Harper, Bausch & Lomb Incorporated

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: January 4, 2008
• First Submitted That Met QC Criteria: January 15, 2008
• First Posted (Estimate): January 16, 2008

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: A9441003