Ocular Hypertension Clinical Trial
Official title:
A 12-Week, Randomized, Double-Masked, Parallel Group Comparison Of Xalacom Given In The Evening, Xalatan Given In The Evening, And Timolol Given In The Morning In Patients With Open Angle Glaucoma Or Ocular Hypertension In The United States.
| NCT number | NCT00277498 |
| Other study ID # | A6641044 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | December 2005 |
| Est. completion date | June 2007 |
| Verified date | June 2008 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To demonstrate statistical superiority of the combination of latanoprost and timolol to the individual therapy of latanoprost and timolol based on intraocular pressure measurements at 8 AM, 10 AM, 4 PM at weeks 2, 6 and 12.
| Status | Completed |
| Enrollment | 528 |
| Est. completion date | June 2007 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening Exclusion Criteria: - Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma. - History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening |
| Country | Name | City | State |
|---|---|---|---|
| United States | Pfizer Investigational Site | Ann Arbor | Michigan |
| United States | Pfizer Investigational Site | Artesia | California |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Austin | Texas |
| United States | Pfizer Investigational Site | Bangor | Maine |
| United States | Pfizer Investigational Site | Birmingham | Alabama |
| United States | Pfizer Investigational Site | Bourbonnais | Illinois |
| United States | Pfizer Investigational Site | Brooklyn | New York |
| United States | Pfizer Investigational Site | Calumet City | Illinois |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Chicago | Illinois |
| United States | Pfizer Investigational Site | Cleveland | Ohio |
| United States | Pfizer Investigational Site | Colorado Springs | Colorado |
| United States | Pfizer Investigational Site | Creve Coeur | Missouri |
| United States | Pfizer Investigational Site | Dallas | Texas |
| United States | Pfizer Investigational Site | Detroit | Michigan |
| United States | Pfizer Investigational Site | Durham | North Carolina |
| United States | Pfizer Investigational Site | Durham | North Carolina |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | El Paso | Texas |
| United States | Pfizer Investigational Site | Evansville | Indiana |
| United States | Pfizer Investigational Site | Flagstaff | Arizona |
| United States | Pfizer Investigational Site | Fort Worth | Texas |
| United States | Pfizer Investigational Site | Fredericksburg | Virginia |
| United States | Pfizer Investigational Site | Gainesville | Florida |
| United States | Pfizer Investigational Site | Greensboro | North Carolina |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Idaho Falls | Idaho |
| United States | Pfizer Investigational Site | Iowa City | Iowa |
| United States | Pfizer Investigational Site | Kansas City | Missouri |
| United States | Pfizer Investigational Site | Lecanto | Florida |
| United States | Pfizer Investigational Site | Los Angeles | California |
| United States | Pfizer Investigational Site | Louisville | Kentucky |
| United States | Pfizer Investigational Site | Madison | Indiana |
| United States | Pfizer Investigational Site | Maryville | Tennessee |
| United States | Pfizer Investigational Site | Miami | Florida |
| United States | Pfizer Investigational Site | New Albany | Indiana |
| United States | Pfizer Investigational Site | New York | New York |
| United States | Pfizer Investigational Site | Newburgh | Indiana |
| United States | Pfizer Investigational Site | Newport Beach | California |
| United States | Pfizer Investigational Site | Panama City | Florida |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Philadelphia | Pennsylvania |
| United States | Pfizer Investigational Site | Piscataway | New Jersey |
| United States | Pfizer Investigational Site | Princeton | New Jersey |
| United States | Pfizer Investigational Site | Reading | Massachusetts |
| United States | Pfizer Investigational Site | Reading | Pennsylvania |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Roseburg | Oregon |
| United States | Pfizer Investigational Site | Sacramento | California |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Francisco | California |
| United States | Pfizer Investigational Site | Seattle | Washington |
| United States | Pfizer Investigational Site | Stillwater | Minnesota |
| United States | Pfizer Investigational Site | Warrensburg | Missouri |
| United States | Pfizer Investigational Site | Washington | Missouri |
| United States | Pfizer Investigational Site | Wichita | Kansas |
| United States | Pfizer Investigational Site | Winston-Salem | North Carolina |
| United States | Pfizer Investigational Site | Wyomissing | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer's Upjohn has merged with Mylan to form Viatris Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The mean IOP measurements obtained in the study eye at each time point. |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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