A 12week, Randomized, Evaluator-Masked, Parallel Group Comparing Evening Dosing Of Xalacom Vs Cosopt In Subj W/ Glaucoma

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

A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.

To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

238

Phase

  • Phase 4

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

  • France
      • Caen, France, 14033
        • Pfizer Investigational Site
      • Clermont-ferrand, France, 63003
        • Pfizer Investigational Site
      • Lyon, France, 69437
        • Pfizer Investigational Site
      • Marseille Cedex 05, France, 13385
        • Pfizer Investigational Site
      • Saint Herblain, France, 44800
        • Pfizer Investigational Site
  • Germany
      • Darmstadt, Germany, 64283
        • Pfizer Investigational Site
      • Darmstadt, Germany, 64297
        • Pfizer Investigational Site
      • Landau / Pfalz, Germany, 76829
        • Pfizer Investigational Site
      • Regenstauf, Germany, 93128
        • Pfizer Investigational Site
      • Schorndorf, Germany, 73614
        • Pfizer Investigational Site
      • Starnberg, Germany, 82319
        • Pfizer Investigational Site
  • Greece
      • Alexandroupoli, Greece, 68100
        • Pfizer Investigational Site
      • Larisa, Greece, 41110
        • Pfizer Investigational Site
    • Crete
      • Heraklion, Crete, Greece, 71110
        • Pfizer Investigational Site
    • Macedonia
      • Thessaloniki, Macedonia, Greece, 546 36
        • Pfizer Investigational Site
  • Italy
      • Chieti, Italy, 66013
        • Pfizer Investigational Site
      • Foggia, Italy, 71100
        • Pfizer Investigational Site
      • Genova, Italy, 16132
        • Pfizer Investigational Site
      • Milano, Italy, 20132
        • Pfizer Investigational Site
      • Monza (MI), Italy, 20052
        • Pfizer Investigational Site
      • Pisa, Italy, 56126
        • Pfizer Investigational Site
  • Sweden
      • Malmo, Sweden, 205 02
        • Pfizer Investigational Site
      • Molndal, Sweden, 431 80
        • Pfizer Investigational Site
      • Sundsvall, Sweden, 851 86
        • Pfizer Investigational Site
      • örebro, Sweden, 703 61
        • 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 Assignment
  • Masking: Single

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.

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

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 30, 2005

First Posted (Estimate)

August 31, 2005

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 17, 2021

Last Verified

November 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6641038

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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