Efficacy And Safety Of Xalatan Compared To Usual Care In Patients With Open Angle Glaucoma Or Ocular Hypertension.

April 4, 2008 updated by: Pfizer

A Randomized Post-Marketing Efficacy And Safety Study Of Xalatan Compared With "Usual Care" Over 36 Months In Patients With Primary Open-Angle Glaucoma, Exfoliative Glaucoma Or Ocular Hypertension

The primary purpose is to compare the intraocular pressure reducing effect of Xalatan with that of usual care over 36 months. Safety and health care utilization will be evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

329

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

  • Finland
      • Helsinki, Finland, 00100
        • Pfizer Investigational Site
      • Helsinki, Finland, 00700
        • Pfizer Investigational Site
      • Kuopio, Finland, 70100
        • Pfizer Investigational Site
      • Lahti, Finland, 15110
        • Pfizer Investigational Site
      • Rovaniemi, Finland, 96200
        • Pfizer Investigational Site
      • Seinajoki, Finland, 60100
        • Pfizer Investigational Site
      • Tammisaari, Finland
        • Pfizer Investigational Site
      • Tampere, Finland, 33100
        • Pfizer Investigational Site
      • Turku, Finland, 20100
        • Pfizer Investigational Site
  • Sweden
      • Jönköping, Sweden, 551 85
        • Pfizer Investigational Site
      • Karlstad, Sweden, 652 20
        • Pfizer Investigational Site
      • Kristianstad, Sweden, 291 31
        • Pfizer Investigational Site
      • Linkoping, Sweden
        • Pfizer Investigational Site
      • Ludvika, Sweden, 771 81
        • Pfizer Investigational Site
      • Molndal, Sweden
        • Pfizer Investigational Site
      • Nacka, Sweden, 131 83
        • Pfizer Investigational Site
      • Norrkoping, Sweden, 601 82
        • Pfizer Investigational Site
      • Norrkoping, Sweden, 602 36
        • Pfizer Investigational Site
      • Nyköping, Sweden
        • Pfizer Investigational Site
      • Orebro, Sweden, 70361
        • Pfizer Investigational Site
      • Seinajoki, Sweden, 151 72
        • Pfizer Investigational Site
      • Stockholm, Sweden
        • Pfizer Investigational Site
      • Stockholm, Sweden, 113 22
        • Pfizer Investigational Site
      • Sundsvall, Sweden, 851 86
        • Pfizer Investigational Site
      • Täby, Sweden, 183 34
        • Pfizer Investigational Site
      • Uppsala, Sweden, 751 85
        • Pfizer Investigational Site
      • Uppsala, Sweden
        • 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:

  • Unilateral or bilateral open-angle glaucoma, exfoliative glaucoma, pigmentary glaucoma or ocular hypertension
  • IOP of > 21 mm Hg on current treatment

Exclusion Criteria:

  • Any previous or current treatment with latanoprost or other prostaglandin analogues

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: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to treatment failure (change or addition of ocular hypertensive medical treatment, ocular surgery or laser trabeculoplasty) of latanoprost monotherapy or usual care over 36 months.

Secondary Outcome Measures

Outcome Measure
Safety and the health care utilization in the two treatment groups over 36 months.

Collaborators and Investigators

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

Sponsor

Pfizer

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

February 1, 2002

Study Completion

April 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 (Estimate)

April 7, 2008

Last Update Submitted That Met QC Criteria

April 4, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 912-OPT-0091-156

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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