Lumigan Versus Cosopt

November 18, 2008 updated by: Pharmaceutical Research Network
To compare the intraocular pressure effect and safety of the dorzolamide/timolol fixed combination given twice daily versus bimatoprost given once every evening in patients with open-angle glaucoma in patients insufficiently controlled on latanoprost monotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

34

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
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Taustine Eye Center
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Glaucoma Consultants & Center for Eye Research, PA
    • Texas
      • Houston, Texas, United States, 77025
        • Houston Eye Associates

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:

  • adults with a diagnosis of bilateral open-angle glaucoma including: primary, pigment dispersion or exfoliation in both eyes
  • on no therapy the intraocular pressure should be 22-29 mm Hg inclusive at the 8:00 AM measurement
  • visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

  • historical failure to respond to topical beta-blockers in a clinically meaningful manner
  • any contraindication to study medications
  • any anticipated change, or modification in the 6 weeks prior to Visit 1, in systemic hypertensive therapy during the trial

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: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Pharmaceutical Research Network

Investigators

  • Study Director: William C. Stewart, MD, Pharmaceutical Research Network, LLC
  • Principal Investigator: Robert D. Williams, MD, Taustine Eye Center
  • Principal Investigator: Robert H. Stewart, MD, Houston Eye Associates
  • Principal Investigator: Elizabeth D. Sharpe, MD, Glaucoma Consultants & Center for Eye Research, PA

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

January 1, 2006

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

January 6, 2006

First Submitted That Met QC Criteria

January 6, 2006

First Posted (Estimate)

January 9, 2006

Study Record Updates

Last Update Posted (Estimate)

November 19, 2008

Last Update Submitted That Met QC Criteria

November 18, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRN 05-017

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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