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Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost
This study has been completed.
Sponsored by: Innovative Medical
Information provided by: Innovative Medical
ClinicalTrials.gov Identifier: NCT00348400
  Purpose

Evaluate the relative efficacy and tolerability of Alphagan P compared to Trusopt as adjunctive therapy


Condition Intervention Phase
Glaucoma
Drug: Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost
Phase IV

Genetics Home Reference related topics: early-onset glaucoma
MedlinePlus related topics: Glaucoma
Drug Information available for: Brimonidine Brimonidine Tartrate Latanoprost Dorzolamide Dorzolamide hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Single Blind, Active Control, Parallel Assignment
Official Title: Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00348400

Locations
United States, Pennsylvania
Dr. Noecker
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Innovative Medical
Investigators
Principal Investigator: Robert Noecker, MD UPMC Eye Center
  More Information

Study ID Numbers: 5099
Study First Received: June 30, 2006
Last Updated: May 30, 2007
ClinicalTrials.gov Identifier: NCT00348400  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Glaucoma
Eye Diseases
Latanoprost
Dorzolamide
Brimonidine
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:
Carbonic Anhydrase Inhibitors
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Adrenergic Agonists

ClinicalTrials.gov processed this record on January 14, 2009