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

Northwestern Ophthalmic Institute S.C.

Status and phase: Completed; Phase 4

Conditions: Ocular Hypertension; Primary Open Angle Glaucoma

Treatments: Drug: Brinzolamide 1%; Drug: Brimonidine purite 0.15%; Drug: Dorzolamide 2%

Study type: Interventional

Funder types: Other

Identifiers

NCT00675207

NWOIADJ 2006

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 41+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

1

Active Comparator group

Description:

Brimonidine purite 0.15%

Treatment:

Drug: Brimonidine purite 0.15%

2

Active Comparator group

Description:

Dorzolamide 2%

Treatment:

Drug: Dorzolamide 2%

3

Active Comparator group

Description:

Brinzolamide 1%

Treatment:

Drug: Brinzolamide 1%