Comparison of Brimonidine Purite, Dorzolamide, and Brinzolamide as Adjunctive Therapy to Prostaglandin Analogs

Overview

The purpose of this study is to compare the efficacy of brimonidine Purite, dorzolamide, and brinzolamide in reducing intraocular pressure when added to prostaglandin analog therapy (bimatoprost, latanoprost, or travoprost) in patients with glaucoma or ocular hypertension.

Full Title of Study: “Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Investigator)
  • Study Primary Completion Date: July 2007

Interventions

  • Drug: Brimonidine purite 0.15%
    • A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.
  • Drug: Dorzolamide 2%
    • A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.
  • Drug: Brinzolamide 1%
    • A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.

Arms, Groups and Cohorts

  • Active Comparator: 1
    • Brimonidine purite 0.15%
  • Active Comparator: 2
    • Dorzolamide 2%
  • Active Comparator: 3
    • Brinzolamide 1%

Clinical Trial Outcome Measures

Primary Measures

  • Intraocular pressure
    • Time Frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of primary open-angle glaucoma or ocular hypertension. – Must be over 40 years of age. – Intraocular pressure must be 18 mm Hg or higher after 6 weeks of treatment (run-in) with a prostaglandin analog (bimatoprost, latanoprost, or travoprost). Exclusion Criteria:

  • History of angle closure or narrow angle. – Previous intraocular surgery. – Laser trabeculoplasty within 3 months prior to screening. – History of uveitis or intraocular inflammation. – Use of medications other than the study medications that are known to affect IOP (e.g., beta-blockers, steroids, or angiotensin II blockers) within 3 months of study entry or during the study. – Intolerance of or hypersensitivity to prostaglandin analogs, sulfonamides, alpha-agonists, or the preservative benzalkonium chloride. – Women of childbearing age who are pregnant or not using contraception.

Gender Eligibility: All

Minimum Age: 41 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern Ophthalmic Institute S.C.
  • Collaborator
    • Research to Prevent Blindness
  • Provider of Information About this Clinical Study
    • Thomas E. Bournias, Northwestern Ophthalmic Institute S.C.
  • Overall Official(s)
    • Thomas E. Bournias, MD, Principal Investigator, Northwestern Ophthalmic Institute S.C.

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