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

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: July 2007

Intervention(s) in this Clinical Trial

• 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 in this Clinical Trial

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

Primary Measures

• Intraocular pressure
  • Time Frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4
    Safety Issue?: No

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 for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 41 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Northwestern Ophthalmic Institute S.C.

Overall Clinical Trial Officials and Contacts

Thomas E. Bournias, MD Principal Investigator Northwestern Ophthalmic Institute S.C.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00675207

Study ID Number: NWOIADJ 2006

ClinicalTrials.gov Identifier: NCT00675207

Health Authority: United States: Institutional Review Board