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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00441883
Other study ID # A9441001
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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