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
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 |
Verified date | September 2020 |
Source | Bausch & Lomb Incorporated |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will evaluate the safety and efficacy of PF 03187207.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Bausch & Lomb Incorporated | NicOx Inc. |
United States,
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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