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

February 17, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

528

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Alabama
  - Birmingham, Alabama, United States, 35216
    - Pfizer Investigational Site
- Arizona
  - Flagstaff, Arizona, United States, 86001
    - Pfizer Investigational Site
- California
  - Artesia, California, United States, 90701
    - Pfizer Investigational Site
  - Los Angeles, California, United States, 90048
    - Pfizer Investigational Site
  - Newport Beach, California, United States, 92663
    - Pfizer Investigational Site
  - Sacramento, California, United States, 95815
    - Pfizer Investigational Site
  - San Francisco, California, United States, 94105
    - Pfizer Investigational Site
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Pfizer Investigational Site
- Florida
  - Gainesville, Florida, United States, 32605
    - Pfizer Investigational Site
  - Lecanto, Florida, United States, 34461
    - Pfizer Investigational Site
  - Miami, Florida, United States, 33136
    - Pfizer Investigational Site
  - Panama City, Florida, United States, 32405
    - Pfizer Investigational Site
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Pfizer Investigational Site
- Illinois
  - Bourbonnais, Illinois, United States, 60914
    - Pfizer Investigational Site
  - Calumet City, Illinois, United States, 60409
    - Pfizer Investigational Site
  - Chicago, Illinois, United States, 60611
    - Pfizer Investigational Site
  - Chicago, Illinois, United States, 60617
    - Pfizer Investigational Site
- Indiana
  - Evansville, Indiana, United States, 47713
    - Pfizer Investigational Site
  - Madison, Indiana, United States, 47250
    - Pfizer Investigational Site
  - New Albany, Indiana, United States, 47150
    - Pfizer Investigational Site
  - Newburgh, Indiana, United States, 47630
    - Pfizer Investigational Site
- Iowa
  - Iowa City, Iowa, United States, 52245
    - Pfizer Investigational Site
- Kansas
  - Wichita, Kansas, United States, 67208
    - Pfizer Investigational Site
- Kentucky
  - Louisville, Kentucky, United States, 40217
    - Pfizer Investigational Site
- Maine
  - Bangor, Maine, United States, 04401
    - Pfizer Investigational Site
- Massachusetts
  - Reading, Massachusetts, United States, 01867
    - Pfizer Investigational Site
- Michigan
  - Ann Arbor, Michigan, United States, 48105
    - Pfizer Investigational Site
  - Detroit, Michigan, United States, 48201-1423
    - Pfizer Investigational Site
- Minnesota
  - Stillwater, Minnesota, United States, 55082
    - Pfizer Investigational Site
- Missouri
  - Creve Coeur, Missouri, United States, 63141-6846
    - Pfizer Investigational Site
  - Kansas City, Missouri, United States, 64114
    - Pfizer Investigational Site
  - Warrensburg, Missouri, United States, 64093
    - Pfizer Investigational Site
  - Washington, Missouri, United States, 63090
    - Pfizer Investigational Site
- New Jersey
  - Piscataway, New Jersey, United States, 08854-4143
    - Pfizer Investigational Site
  - Princeton, New Jersey, United States, 08540-3211
    - Pfizer Investigational Site
- New York
  - Brooklyn, New York, United States, 11215
    - Pfizer Investigational Site
  - New York, New York, United States, 10032-3701
    - Pfizer Investigational Site
  - Rochester, New York, United States, 14618
    - Pfizer Investigational Site
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Pfizer Investigational Site
  - Durham, North Carolina, United States, 27704-2122
    - Pfizer Investigational Site
  - Greensboro, North Carolina, United States, 27408-7022
    - Pfizer Investigational Site
  - Winston-Salem, North Carolina, United States, 27101
    - Pfizer Investigational Site
- Ohio
  - Cleveland, Ohio, United States, 44115-3176
    - Pfizer Investigational Site
- Oregon
  - Roseburg, Oregon, United States, 97470
    - Pfizer Investigational Site
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19114
    - Pfizer Investigational Site
  - Philadelphia, Pennsylvania, United States, 19148
    - Pfizer Investigational Site
  - Reading, Pennsylvania, United States, 19606
    - Pfizer Investigational Site
  - Wyomissing, Pennsylvania, United States, 19610
    - Pfizer Investigational Site
- South Carolina
  - Charleston, South Carolina, United States, 29403
    - Pfizer Investigational Site
  - Charleston, South Carolina, United States, 29414
    - Pfizer Investigational Site
- Tennessee
  - Maryville, Tennessee, United States, 37803
    - Pfizer Investigational Site
- Texas
  - Austin, Texas, United States, 78705
    - Pfizer Investigational Site
  - Austin, Texas, United States, 78746
    - Pfizer Investigational Site
  - Dallas, Texas, United States, 75231-5185
    - Pfizer Investigational Site
  - El Paso, Texas, United States, 79902
    - Pfizer Investigational Site
  - El Paso, Texas, United States, 79904
    - Pfizer Investigational Site
  - Fort Worth, Texas, United States, 76102-4427
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77055
    - Pfizer Investigational Site
  - Houston, Texas, United States, 77025-1635
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78209
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78240
    - Pfizer Investigational Site
  - San Antonio, Texas, United States, 78205
    - Pfizer Investigational Site
- Virginia
  - Fredericksburg, Virginia, United States, 22405
    - Pfizer Investigational Site
- Washington
  - Seattle, Washington, United States, 98133
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The mean IOP measurements obtained in the study eye at each time point.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

January 13, 2006

First Submitted That Met QC Criteria

January 13, 2006

First Posted (Estimate)

January 16, 2006

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

June 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A6641044

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.