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.

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 (Actual)

500

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

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5R6
        • Pfizer Investigational Site
    • British Columbia
      • Nanaimo, British Columbia, Canada, V9R 5B6
        • Pfizer Investigational Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 2N7
        • Pfizer Investigational Site
      • Saint John, New Brunswick, Canada, E2L 1G3
        • Pfizer Investigational Site
      • Saint John, New Brunswick, Canada, E2L 4W3
        • Pfizer Investigational Site
    • Nova Scotia
      • Bridgewater, Nova Scotia, Canada, B4V 3N2
        • Pfizer Investigational Site
    • Ontario
      • Barrie, Ontario, Canada, L4M 4S5
        • Pfizer Investigational Site
      • Markham, Ontario, Canada, L6B 1A1
        • Pfizer Investigational Site
      • Mississauga, Ontario, Canada, L5A 4E4
        • Pfizer Investigational Site
      • Oakville, Ontario, Canada, L6H 3P1
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M5B 1W8
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6H 2H1
        • Pfizer Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, H1T 2M4
        • Pfizer Investigational Site
      • Montreal, Quebec, Canada, H1V 1G5
        • Pfizer Investigational Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7K 3H3
        • Pfizer Investigational Site
      • Saskatoon, Saskatchewan, Canada, S7K 0M7
        • Pfizer Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85032
        • Pfizer Investigational Site
    • California
      • Poway, California, United States, 92064
        • Pfizer Investigational Site
      • Redding, California, United States, 96002-2122
        • Pfizer Investigational Site
      • Redding, California, United States, 96002
        • Pfizer Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810-4004
        • Pfizer Investigational Site
    • Florida
      • Cape Coral, Florida, United States, 33904
        • Pfizer Investigational Site
      • Lakeland, Florida, United States, 33805-2440
        • Pfizer Investigational Site
      • Ormond Beach, Florida, United States, 32174
        • Pfizer Investigational Site
      • Tampa, Florida, United States, 33603
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30322
        • Pfizer Investigational Site
      • Atlanta, Georgia, United States, 30349
        • Pfizer Investigational Site
      • Morrow, Georgia, United States, 30260
        • Pfizer Investigational Site
    • Illinois
      • Homewood, Illinois, United States, 60430
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • Pfizer Investigational Site
    • Massachusetts
      • North Dartmouth, Massachusetts, United States, 02747
        • Pfizer Investigational Site
    • Michigan
      • Saint Joseph, Michigan, United States, 49085
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Pfizer Investigational Site
      • Omaha, Nebraska, United States, 68198-5540
        • Pfizer Investigational Site
    • New Jersey
      • Newark, New Jersey, United States, 07103-2499
        • Pfizer Investigational Site
    • New York
      • Bethpage, New York, United States, 11714-5701
        • Pfizer Investigational Site
      • New York, New York, United States, 10029-6574
        • Pfizer Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28262
        • Pfizer Investigational Site
      • Charlotte, North Carolina, United States, 28210
        • Pfizer Investigational Site
      • High Point, North Carolina, United States, 27262
        • Pfizer Investigational Site
      • Matthews, North Carolina, United States, 28105
        • Pfizer Investigational Site
      • Wilmington, North Carolina, United States, 28403
        • Pfizer Investigational Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Pfizer Investigational Site
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15238-3103
        • Pfizer Investigational Site
    • South Carolina
      • Mount Pleasant, South Carolina, United States, 29464
        • Pfizer Investigational Site
      • Mount Pleasant, South Carolina, United States, 29464-3060
        • Pfizer Investigational Site
      • North Charleston, South Carolina, United States, 29406
        • Pfizer Investigational Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Pfizer Investigational Site
    • Texas
      • Amarillo, Texas, United States, 79106
        • Pfizer Investigational Site
      • Houston, Texas, United States, 77030
        • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

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
  • 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.

Helpful Links

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

July 1, 2005

Primary Completion (ACTUAL)

June 1, 2007

Study Completion (ACTUAL)

June 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (ESTIMATE)

September 12, 2005

Study Record Updates

Last Update Posted (ACTUAL)

February 21, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

October 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6641027

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.

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