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

NCT ID: NCT00675207

Last Updated: 2008-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-07-31

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.

Detailed Description

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Conditions

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Primary Open Angle Glaucoma Ocular Hypertension

Keywords

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glaucoma ocular hypertension adjunctive treatment prostaglandin prostaglandin analog brimonidine dorzolamide brinzolamide alpha agonist carbonic anhydrase inhibitor intraocular pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Brimonidine purite 0.15%

Group Type ACTIVE_COMPARATOR

Brimonidine purite 0.15%

Intervention Type DRUG

A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.

2

Dorzolamide 2%

Group Type ACTIVE_COMPARATOR

Dorzolamide 2%

Intervention Type DRUG

A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.

3

Brinzolamide 1%

Group Type ACTIVE_COMPARATOR

Brinzolamide 1%

Intervention Type DRUG

A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.

Interventions

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Brimonidine purite 0.15%

A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.

Intervention Type DRUG

Dorzolamide 2%

A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.

Intervention Type DRUG

Brinzolamide 1%

A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.

Intervention Type DRUG

Other Intervention Names

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Alphagan P 0.15% Trusopt Azopt

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.
Minimum Eligible Age

41 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research to Prevent Blindness

OTHER

Sponsor Role collaborator

Northwestern Ophthalmic Institute S.C.

OTHER

Sponsor Role lead

Responsible Party

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Northwestern Ophthalmic Institute S.C.

Principal Investigators

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Thomas E. Bournias, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern Ophthalmic Institute S.C.

Locations

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Northwestern Ophthalmic Institute S.C.

Glenview, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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NWOIADJ 2006

Identifier Type: -

Identifier Source: org_study_id