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

Phase 4

Completed

• Conditions: Primary Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: Dorzolamide 2%; Drug: Brimonidine purite 0.15%; Drug: Brinzolamide 1%

• Registration Number: NCT00675207
• Lead Sponsor: Northwestern Ophthalmic Institute S.C.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2008-05
• Study First Submitted: 2008-05-06
• Study First Submitted QC: 2008-05-06
• Last Update Submitted: 2008-05-06
• Study First Posted: 2008-05-08
• Last Update Posted: 2008-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Dorzolamide 2%	Dorzolamide 2%
1	Brimonidine purite 0.15%	Brimonidine purite 0.15%
3	Brinzolamide 1%	Brinzolamide 1%

Primary Outcome Measures

Name	Time	Method
Intraocular pressure	Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4

Trial Locations

Locations (1)

Northwestern Ophthalmic Institute S.C.; 🇺🇸 Glenview, Illinois, United States