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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00441883
• Other study ID #: A9441001
• Status: Completed
• Phase: Phase 2
• Start date: March 2007
• Est. completion date: July 2008

Study information

• Verified date: September 2020
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: July 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension
• Pigmentary Glaucoma
• Primary Open Angle Glaucoma
• Pseudoexfoliative Glaucoma

Intervention

Drug:
• PF-03187207 and Latanoprost Vehicle

• Latanoprost 0.005% and PF-03187207 Vehicle

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Artesia	California
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Atlanta	Georgia
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Charlotte	North Carolina
United States	Pfizer Investigational Site	Cranberry Township	Pennsylvania
United States	Pfizer Investigational Site	Danbury	Connecticut
United States	Pfizer Investigational Site	Evansville	Indiana
United States	Pfizer Investigational Site	High Point	North Carolina
United States	Pfizer Investigational Site	Jacksonville	Florida
United States	Pfizer Investigational Site	Louisville	Kentucky
United States	Pfizer Investigational Site	Memphis	Tennessee
United States	Pfizer Investigational Site	Newport Beach	California
United States	Pfizer Investigational Site	Ormond Beach	Florida
United States	Pfizer Investigational Site	Petaluma	California
United States	Pfizer Investigational Site	Pittsburgh	Pennsylvania
United States	Pfizer Investigational Site	Poway	California
United States	Pfizer Investigational Site	Rochester	New York
United States	Pfizer Investigational Site	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated	NicOx Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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