A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma
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.
1 other identifier
interventional
528
1 country
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2005
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
January 13, 2006
CompletedFirst Posted
Study publicly available on registry
January 16, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2007
CompletedFebruary 18, 2021
June 1, 2008
January 13, 2006
February 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The mean IOP measurements obtained in the study eye at each time point.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Pfizer Investigational Site
Birmingham, Alabama, 35216, United States
Pfizer Investigational Site
Flagstaff, Arizona, 86001, United States
Pfizer Investigational Site
Artesia, California, 90701, United States
Pfizer Investigational Site
Los Angeles, California, 90048, United States
Pfizer Investigational Site
Newport Beach, California, 92663, United States
Pfizer Investigational Site
Sacramento, California, 95815, United States
Pfizer Investigational Site
San Francisco, California, 94105, United States
Pfizer Investigational Site
Colorado Springs, Colorado, 80907, United States
Pfizer Investigational Site
Gainesville, Florida, 32605, United States
Pfizer Investigational Site
Lecanto, Florida, 34461, United States
Pfizer Investigational Site
Miami, Florida, 33136, United States
Pfizer Investigational Site
Panama City, Florida, 32405, United States
Pfizer Investigational Site
Idaho Falls, Idaho, 83404, United States
Pfizer Investigational Site
Bourbonnais, Illinois, 60914, United States
Pfizer Investigational Site
Calumet City, Illinois, 60409, United States
Pfizer Investigational Site
Chicago, Illinois, 60611, United States
Pfizer Investigational Site
Chicago, Illinois, 60617, United States
Pfizer Investigational Site
Evansville, Indiana, 47713, United States
Pfizer Investigational Site
Madison, Indiana, 47250, United States
Pfizer Investigational Site
New Albany, Indiana, 47150, United States
Pfizer Investigational Site
Newburgh, Indiana, 47630, United States
Pfizer Investigational Site
Iowa City, Iowa, 52245, United States
Pfizer Investigational Site
Wichita, Kansas, 67208, United States
Pfizer Investigational Site
Louisville, Kentucky, 40217, United States
Pfizer Investigational Site
Bangor, Maine, 04401, United States
Pfizer Investigational Site
Reading, Massachusetts, 01867, United States
Pfizer Investigational Site
Ann Arbor, Michigan, 48105, United States
Pfizer Investigational Site
Detroit, Michigan, 48201-1423, United States
Pfizer Investigational Site
Stillwater, Minnesota, 55082, United States
Pfizer Investigational Site
Creve Coeur, Missouri, 63141-6846, United States
Pfizer Investigational Site
Kansas City, Missouri, 64114, United States
Pfizer Investigational Site
Warrensburg, Missouri, 64093, United States
Pfizer Investigational Site
Washington, Missouri, 63090, United States
Pfizer Investigational Site
Piscataway, New Jersey, 08854-4143, United States
Pfizer Investigational Site
Princeton, New Jersey, 08540-3211, United States
Pfizer Investigational Site
Brooklyn, New York, 11215, United States
Pfizer Investigational Site
New York, New York, 10032-3701, United States
Pfizer Investigational Site
Rochester, New York, 14618, United States
Pfizer Investigational Site
Durham, North Carolina, 27704-2122, United States
Pfizer Investigational Site
Durham, North Carolina, 27710, United States
Pfizer Investigational Site
Greensboro, North Carolina, 27408-7022, United States
Pfizer Investigational Site
Winston-Salem, North Carolina, 27101, United States
Pfizer Investigational Site
Cleveland, Ohio, 44115-3176, United States
Pfizer Investigational Site
Roseburg, Oregon, 97470, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114, United States
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19148, United States
Pfizer Investigational Site
Reading, Pennsylvania, 19606, United States
Pfizer Investigational Site
Wyomissing, Pennsylvania, 19610, United States
Pfizer Investigational Site
Charleston, South Carolina, 29403, United States
Pfizer Investigational Site
Charleston, South Carolina, 29414, United States
Pfizer Investigational Site
Maryville, Tennessee, 37803, United States
Pfizer Investigational Site
Austin, Texas, 78705, United States
Pfizer Investigational Site
Austin, Texas, 78746, United States
Pfizer Investigational Site
Dallas, Texas, 75231-5185, United States
Pfizer Investigational Site
El Paso, Texas, 79902, United States
Pfizer Investigational Site
El Paso, Texas, 79904, United States
Pfizer Investigational Site
Fort Worth, Texas, 76102-4427, United States
Pfizer Investigational Site
Houston, Texas, 77025-1635, United States
Pfizer Investigational Site
Houston, Texas, 77055, United States
Pfizer Investigational Site
San Antonio, Texas, 78205, United States
Pfizer Investigational Site
San Antonio, Texas, 78209, United States
Pfizer Investigational Site
San Antonio, Texas, 78240, United States
Pfizer Investigational Site
Fredericksburg, Virginia, 22405, United States
Pfizer Investigational Site
Seattle, Washington, 98133, United States
Related Publications (1)
Higginbotham EJ, Olander KW, Kim EE, Grunden JW, Kwok KK, Tressler CS; United States Fixed-Combination Study Group. Fixed combination of latanoprost and timolol vs individual components for primary open-angle glaucoma or ocular hypertension: a randomized, double-masked study. Arch Ophthalmol. 2010 Feb;128(2):165-72. doi: 10.1001/archophthalmol.2009.384.
PMID: 20142538DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2006
First Posted
January 16, 2006
Study Start
December 1, 2005
Study Completion
June 1, 2007
Last Updated
February 18, 2021
Record last verified: 2008-06