Assessing Cosopt Switch Patients

November 18, 2008 updated by: Pharmaceutical Research Network
To assess the safety and efficacy of a cohort of patients switched to the dorzolamide/timolol maleate fixed combination because they are insufficiently controlled on latanoprost monotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Little Rock Eye Clinic
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Omni Eye Services
    • Illinois
      • Bourbonnais, Illinois, United States, 60914
        • Midwest Eye Center
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Mark J. Weiss, MD
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464
        • Glaucoma Consultants & Center for Eye Research

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 clinical diagnosis of POAG, pigment-dispersion or exfoliation glaucoma or ocular hypertension
  • the IOP on latanoprost must be 31 mm Hg or less in both eyes, and 21 to 31 mm Hg inclusive in at least one eye at 08:00 AM
  • visual acuity should be 20/200 or better in each eye

Exclusion Criteria:

  • contraindications to study drugs
  • anticipated change in systemic hypotensive therapy during the trial
  • use of any corticosteroids by any route in the three months immediately prior to Visit 2

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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: Mark J. Weiss, MD
  • Principal Investigator: Douglas G. Day, MD, Omni Eye Services
  • Principal Investigator: Sriram Sonty, MD, FACS, Midwest Eye Center
  • Principal Investigator: J. Charles Henry, MD, Little Rock Eye Clinic
  • Principal Investigator: Elizabeth D. Sharpe, MD, Glaucoma Consultants & Center for Eye Research

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

November 1, 2005

Study Completion (Actual)

April 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 05-007

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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