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

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ClinicalTrials.gov Identifier: NCT00348400
Recruitment Status : Completed
First Posted : July 4, 2006
Last Update Posted : June 1, 2007
Sponsor:
Information provided by:
Innovative Medical

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

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Brimonidine Purite 0.15%, Dorzolamide 2%, Latanoprost Phase 4

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






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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00348400


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

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ClinicalTrials.gov Identifier: NCT00348400     History of Changes
Other Study ID Numbers: 5099
First Posted: July 4, 2006    Key Record Dates
Last Update Posted: June 1, 2007
Last Verified: May 2007
Additional relevant MeSH terms:
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Brimonidine Tartrate
Glaucoma
Ocular Hypertension
Eye Diseases
Latanoprost
Dorzolamide
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors