A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00277498
Collaborator
(none)
528
64
18
8.3
0.5
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double
Primary Purpose:
Treatment
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.
Study Start Date
:
Dec 1, 2005
Actual Study Completion Date
:
Jun 1, 2007
Outcome Measures
Primary Outcome Measures
- The mean IOP measurements obtained in the study eye at each time point. []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Birmingham | Alabama | United States | 35216 |
| 2 | Pfizer Investigational Site | Flagstaff | Arizona | United States | 86001 |
| 3 | Pfizer Investigational Site | Artesia | California | United States | 90701 |
| 4 | Pfizer Investigational Site | Los Angeles | California | United States | 90048 |
| 5 | Pfizer Investigational Site | Newport Beach | California | United States | 92663 |
| 6 | Pfizer Investigational Site | Sacramento | California | United States | 95815 |
| 7 | Pfizer Investigational Site | San Francisco | California | United States | 94105 |
| 8 | Pfizer Investigational Site | Colorado Springs | Colorado | United States | 80907 |
| 9 | Pfizer Investigational Site | Gainesville | Florida | United States | 32605 |
| 10 | Pfizer Investigational Site | Lecanto | Florida | United States | 34461 |
| 11 | Pfizer Investigational Site | Miami | Florida | United States | 33136 |
| 12 | Pfizer Investigational Site | Panama City | Florida | United States | 32405 |
| 13 | Pfizer Investigational Site | Idaho Falls | Idaho | United States | 83404 |
| 14 | Pfizer Investigational Site | Bourbonnais | Illinois | United States | 60914 |
| 15 | Pfizer Investigational Site | Calumet City | Illinois | United States | 60409 |
| 16 | Pfizer Investigational Site | Chicago | Illinois | United States | 60611 |
| 17 | Pfizer Investigational Site | Chicago | Illinois | United States | 60617 |
| 18 | Pfizer Investigational Site | Evansville | Indiana | United States | 47713 |
| 19 | Pfizer Investigational Site | Madison | Indiana | United States | 47250 |
| 20 | Pfizer Investigational Site | New Albany | Indiana | United States | 47150 |
| 21 | Pfizer Investigational Site | Newburgh | Indiana | United States | 47630 |
| 22 | Pfizer Investigational Site | Iowa City | Iowa | United States | 52245 |
| 23 | Pfizer Investigational Site | Wichita | Kansas | United States | 67208 |
| 24 | Pfizer Investigational Site | Louisville | Kentucky | United States | 40217 |
| 25 | Pfizer Investigational Site | Bangor | Maine | United States | 04401 |
| 26 | Pfizer Investigational Site | Reading | Massachusetts | United States | 01867 |
| 27 | Pfizer Investigational Site | Ann Arbor | Michigan | United States | 48105 |
| 28 | Pfizer Investigational Site | Detroit | Michigan | United States | 48201-1423 |
| 29 | Pfizer Investigational Site | Stillwater | Minnesota | United States | 55082 |
| 30 | Pfizer Investigational Site | Creve Coeur | Missouri | United States | 63141-6846 |
| 31 | Pfizer Investigational Site | Kansas City | Missouri | United States | 64114 |
| 32 | Pfizer Investigational Site | Warrensburg | Missouri | United States | 64093 |
| 33 | Pfizer Investigational Site | Washington | Missouri | United States | 63090 |
| 34 | Pfizer Investigational Site | Piscataway | New Jersey | United States | 08854-4143 |
| 35 | Pfizer Investigational Site | Princeton | New Jersey | United States | 08540-3211 |
| 36 | Pfizer Investigational Site | Brooklyn | New York | United States | 11215 |
| 37 | Pfizer Investigational Site | New York | New York | United States | 10032-3701 |
| 38 | Pfizer Investigational Site | Rochester | New York | United States | 14618 |
| 39 | Pfizer Investigational Site | Durham | North Carolina | United States | 27704-2122 |
| 40 | Pfizer Investigational Site | Durham | North Carolina | United States | 27710 |
| 41 | Pfizer Investigational Site | Greensboro | North Carolina | United States | 27408-7022 |
| 42 | Pfizer Investigational Site | Winston-Salem | North Carolina | United States | 27101 |
| 43 | Pfizer Investigational Site | Cleveland | Ohio | United States | 44115-3176 |
| 44 | Pfizer Investigational Site | Roseburg | Oregon | United States | 97470 |
| 45 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19114 |
| 46 | Pfizer Investigational Site | Philadelphia | Pennsylvania | United States | 19148 |
| 47 | Pfizer Investigational Site | Reading | Pennsylvania | United States | 19606 |
| 48 | Pfizer Investigational Site | Wyomissing | Pennsylvania | United States | 19610 |
| 49 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29403 |
| 50 | Pfizer Investigational Site | Charleston | South Carolina | United States | 29414 |
| 51 | Pfizer Investigational Site | Maryville | Tennessee | United States | 37803 |
| 52 | Pfizer Investigational Site | Austin | Texas | United States | 78705 |
| 53 | Pfizer Investigational Site | Austin | Texas | United States | 78746 |
| 54 | Pfizer Investigational Site | Dallas | Texas | United States | 75231-5185 |
| 55 | Pfizer Investigational Site | El Paso | Texas | United States | 79902 |
| 56 | Pfizer Investigational Site | El Paso | Texas | United States | 79904 |
| 57 | Pfizer Investigational Site | Fort Worth | Texas | United States | 76102-4427 |
| 58 | Pfizer Investigational Site | Houston | Texas | United States | 77025-1635 |
| 59 | Pfizer Investigational Site | Houston | Texas | United States | 77055 |
| 60 | Pfizer Investigational Site | San Antonio | Texas | United States | 78205 |
| 61 | Pfizer Investigational Site | San Antonio | Texas | United States | 78209 |
| 62 | Pfizer Investigational Site | San Antonio | Texas | United States | 78240 |
| 63 | Pfizer Investigational Site | Fredericksburg | Virginia | United States | 22405 |
| 64 | Pfizer Investigational Site | Seattle | Washington | United States | 98133 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00277498
Other Study ID Numbers:
- A6641044
First Posted:
Jan 16, 2006
Last Update Posted:
Feb 18, 2021
Last Verified:
Jun 1, 2008
Additional relevant MeSH terms: