Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

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

An 8-Week, Randomized, Open-Label, Parallel Group Study Comparing The Efficacy And Safety Of Xalacom With The Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

240

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

  • China
      • Shanghai, China, 200031
        • Pfizer Investigational Site
    • Beijing
      • Beijing, Beijing, China, 100034
        • Pfizer Investigational Site
      • Beijing, Beijing, China, 100730
        • Pfizer Investigational Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Pfizer Investigational Site
    • Shanghai
      • Shanghai, Shanghai, China, 200092
        • Pfizer Investigational Site
    • Shanxi
      • Xi?an, Shanxi, China, 710004
        • Pfizer Investigational Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Pfizer Investigational Site
      • Hangzhou, Zhejiang, China, 310009
        • 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:

  • patients with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • closed/barely open anterior chamber angle or a history of acute angel closure glaucoma
  • Ocular surgery within 3 months

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: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension

Secondary Outcome Measures

Outcome Measure
To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits

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

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

June 1, 2005

Study Completion (ACTUAL)

September 1, 2006

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 14, 2005

First Posted (ESTIMATE)

September 22, 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, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A6641028

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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