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

Study Overview
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Brief Summary
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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.

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

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Brimonidine purite 0.15%
* Drug: Dorzolamide 2%
* Drug: Brinzolamide 1%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 41 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Brimonidine purite 0.15% | Drug: Brimonidine purite 0.15%<br>* A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.<br>* Other names: Alphagan P 0.15%;|
| Active Comparator: 2<br>Dorzolamide 2% | Drug: Dorzolamide 2%<br>* A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.<br>* Other names: Trusopt;|
| Active Comparator: 3<br>Brinzolamide 1% | Drug: Brinzolamide 1%<br>* A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.<br>* Other names: Azopt;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure |  | Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, ocular hypertension, adjunctive treatment, prostaglandin, prostaglandin analog, brimonidine, dorzolamide, brinzolamide, alpha agonist, carbonic anhydrase inhibitor, intraocular pressure