Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost

May 30, 2007 updated by: Innovative Medical
Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy

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 open-angle glaucoma or ocular hypertension
    • IOP > 16 mm Hg in each eye at the latanoprost -treated baseline evaluation
    • Presently on latanoprost monotherapy for at least 6 weeks
    • Ability to provide informed consent and likely to complete all study visits

Exclusion Criteria:

  • · Known contraindication or allergy to brimonidine or any of its components

    • Subjects must be naive to brimonidine 0.2% or brimonidine Purite 0.15% and dorzolamide 2%
    • Uncontrolled systemic disease
    • Active ocular disease other than glaucoma or ocular hypertension (e.g. uveitis, ocular infections, or severe dry eye). Patients with chronic mild blepharitis, cataract, age-related macular degeneration, or background diabetic retinopathy may be enrolled at the discretion of the investigator.
    • Required use of ocular medications other than the study medications during the study (intermittent use of artificial tear product is allowed).
    • Corneal abnormalities
    • History of intraocular surgery within the last 3 months
    • Female patients of childbearing potential who are pregnant, lactating, planning a pregnancy, or not using a reliable form of birth control
    • Visual field loss, which in the opinion of the investigator, is functionally significant, or evidence of progressive visual field loss within the last year.

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)

June 1, 2007

Last Update Submitted That Met QC Criteria

May 30, 2007

Last Verified

May 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5099

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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