A 12-week, Randomized, Double-masked, Parallel Group Comparison of Evening Dosing With Xalacom in Subjects With Glaucoma

NCT ID: NCT00277498

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

528 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Open Angle Glaucoma Ocular Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Xalacom

Intervention Type DRUG

Xalatan

Intervention Type DRUG

Timolol

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Birmingham, Alabama, United States

Site Status

Pfizer Investigational Site

Flagstaff, Arizona, United States

Site Status

Pfizer Investigational Site

Artesia, California, United States

Site Status

Pfizer Investigational Site

Los Angeles, California, United States

Site Status

Pfizer Investigational Site

Newport Beach, California, United States

Site Status

Pfizer Investigational Site

Sacramento, California, United States

Site Status

Pfizer Investigational Site

San Francisco, California, United States

Site Status

Pfizer Investigational Site

Colorado Springs, Colorado, United States

Site Status

Pfizer Investigational Site

Gainesville, Florida, United States

Site Status

Pfizer Investigational Site

Lecanto, Florida, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

Panama City, Florida, United States

Site Status

Pfizer Investigational Site

Idaho Falls, Idaho, United States

Site Status

Pfizer Investigational Site

Bourbonnais, Illinois, United States

Site Status

Pfizer Investigational Site

Calumet City, Illinois, United States

Site Status

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

Chicago, Illinois, United States

Site Status

Pfizer Investigational Site

Evansville, Indiana, United States

Site Status

Pfizer Investigational Site

Madison, Indiana, United States

Site Status

Pfizer Investigational Site

New Albany, Indiana, United States

Site Status

Pfizer Investigational Site

Newburgh, Indiana, United States

Site Status

Pfizer Investigational Site

Iowa City, Iowa, United States

Site Status

Pfizer Investigational Site

Wichita, Kansas, United States

Site Status

Pfizer Investigational Site

Louisville, Kentucky, United States

Site Status

Pfizer Investigational Site

Bangor, Maine, United States

Site Status

Pfizer Investigational Site

Reading, Massachusetts, United States

Site Status

Pfizer Investigational Site

Ann Arbor, Michigan, United States

Site Status

Pfizer Investigational Site

Detroit, Michigan, United States

Site Status

Pfizer Investigational Site

Stillwater, Minnesota, United States

Site Status

Pfizer Investigational Site

Creve Coeur, Missouri, United States

Site Status

Pfizer Investigational Site

Kansas City, Missouri, United States

Site Status

Pfizer Investigational Site

Warrensburg, Missouri, United States

Site Status

Pfizer Investigational Site

Washington, Missouri, United States

Site Status

Pfizer Investigational Site

Piscataway, New Jersey, United States

Site Status

Pfizer Investigational Site

Princeton, New Jersey, United States

Site Status

Pfizer Investigational Site

Brooklyn, New York, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Rochester, New York, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Durham, North Carolina, United States

Site Status

Pfizer Investigational Site

Greensboro, North Carolina, United States

Site Status

Pfizer Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Roseburg, Oregon, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Reading, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Wyomissing, Pennsylvania, United States

Site Status

Pfizer Investigational Site

Charleston, South Carolina, United States

Site Status

Pfizer Investigational Site

Charleston, South Carolina, United States

Site Status

Pfizer Investigational Site

Maryville, Tennessee, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Pfizer Investigational Site

Austin, Texas, United States

Site Status

Pfizer Investigational Site

Dallas, Texas, United States

Site Status

Pfizer Investigational Site

El Paso, Texas, United States

Site Status

Pfizer Investigational Site

El Paso, Texas, United States

Site Status

Pfizer Investigational Site

Fort Worth, Texas, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

Houston, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

San Antonio, Texas, United States

Site Status

Pfizer Investigational Site

Fredericksburg, Virginia, United States

Site Status

Pfizer Investigational Site

Seattle, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 20142538 (View on PubMed)

Related Links

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6641044

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Cosopt Versus Xalatan
NCT00273429 COMPLETED PHASE4