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

Sponsor
Innovative Medical (Industry)
Overall Status
Completed
CT.gov ID
NCT00348400
Collaborator
(none)
1
Location

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost
 Phase 4

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single
Official Title:
Brimonidine Purite 0.15% Versus Dorzolamide 2% Used as Adjunctive Therapy to Latanoprost

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Locations

    Site City State Country Postal Code
    1 Dr. Noecker Pittsburgh Pennsylvania United States 15213

    Sponsors and Collaborators

    • Innovative Medical

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00348400
    Other Study ID Numbers:
    • 5099
    First Posted:
    Jul 4, 2006
    Last Update Posted:
    Jun 1, 2007
    Last Verified:
    May 1, 2007
    Additional relevant MeSH terms:
    Glaucoma
    Brimonidine Tartrate
    Dorzolamide
    Latanoprost

    Study Results

    No Results Posted as of Jun 1, 2007