Dose-Finding Study Comparing the Safety and Efficacy of Latanoprost to a Novel Treatment for Glaucoma

A Phase 2, 28 Day Parallel-Group, Double-Masked, Dose-Finding Study Comparing the Safety and Efficacy of PF-03187207 to Latanoprost

This study will evaluate the safety and efficacy of PF 03187207.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 176
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Pfizer Investigational Site
    • Newport Beach, California, United States, 92663
      • Pfizer Investigational Site
    • Petaluma, California, United States, 94954
      • Pfizer Investigational Site
    • Poway, California, United States, 92064
      • Pfizer Investigational Site
  • Connecticut
    • Danbury, Connecticut, United States, 06810-4004
      • Pfizer Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32204
      • Pfizer Investigational Site
    • Ormond Beach, Florida, United States, 32174
      • Pfizer Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Pfizer Investigational Site
    • Atlanta, Georgia, United States, 30339
      • Pfizer Investigational Site
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Pfizer Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Pfizer Investigational Site
  • New York
    • Rochester, New York, United States, 14618
      • Pfizer Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
      • Pfizer Investigational Site
    • High Point, North Carolina, United States, 27262
      • Pfizer Investigational Site
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Pfizer Investigational Site
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Pfizer Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15238
      • Pfizer Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

-Diagnosis of primary open angle glaucoma (including pigmentary or pseudoexfoliative) or ocular hypertension in one or both eyes

Exclusion Criteria:

-Closed or barely open anterior chamber angle or a history of acute angle closure in either eye

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PF-03187207 and Latanoprost Vehicle; One drop of each, once daily in study eye for 28 days	Drug: PF-03187207 and Latanoprost Vehicle
Active Comparator: Latanoprost 0.005% and PF-03187207 Vehicle; One drop of each, once daily in study eye for 28 days	Drug: Latanoprost 0.005% and PF-03187207 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 the Day 7, 14, and 21 Visits	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.	Baseline, Day 7, Day 14, and Day 21
Percentage of Participants With Intraocular Pressure (IOP) Less Than or Equal to 18 mmHg 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.	28 days

Collaborators and Investigators

• Sponsor: Bausch & Lomb Incorporated
• Collaborators: NicOx Inc.
• Investigators: Study Director: Kenneth Harper, Bausch & Lomb Incorporated

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): February 1, 2008
• Study Completion (Actual): July 1, 2008

Study Registration Dates

• First Submitted: February 27, 2007
• First Submitted That Met QC Criteria: February 27, 2007
• First Posted (Estimate): March 1, 2007

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: Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Pharmaceutical Solutions; Ophthalmic Solutions; Latanoprost
• Other Study ID Numbers: A9441001