Bimatoprost Monotherapy vs. Dual Therapy With Travoprost and Timolol in Patients With Glaucoma and Ocular Hypertension

February 7, 2007 updated by: Innovative Medical

Comparison of Bimatoprost 0.03% Monotherapy vs. Dual Therapy With Travoprost 0.004% and Timolol 0.5% in Patients With Glaucoma and Ocular Hypertension

Evaluate the IOP-lowering efficacy and quality of life in patients using bimatoprost 0.03% monotherapy versus dual therapy with travoprost 0.004% and timolol 0.5% for the treatment of glaucoma or ocular hypertension.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Dr. Noecker

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

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • · Male or female > 18 years of age

    • Diagnosis of primary open-angle glaucoma or ocular hypertension
    • Untreated IOP > 18 mm Hg in each eye at the baseline evaluation
    • Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

  • · Known contraindication to bimatoprost, travoprost, timolol, or any component of any study medication

    • Uncontrolled systemic disease
    • Active ocular disease other than POAG or ocular hypertension
    • Required use of ocular medications other than the study medications during the study (intermittent use of OTC artificial tear products will be permitted)
    • History of intraocular surgery within the last 3 months
    • Patient must not have discontinued use of any medication included in this study in the past for reasons of efficacy or intolerance

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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

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

Sponsor

Innovative Medical

Investigators

  • Principal Investigator: Robert Noecker, MD, UPMC Eye Center

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 Registration Dates

First Submitted

June 30, 2006

First Submitted That Met QC Criteria

June 30, 2006

First Posted (Estimate)

July 4, 2006

Study Record Updates

Last Update Posted (Estimate)

February 9, 2007

Last Update Submitted That Met QC Criteria

February 7, 2007

Last Verified

February 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5179

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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