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

Information source: Northwestern Ophthalmic Institute S.C.
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Primary Open Angle Glaucoma; Ocular Hypertension

Intervention: Brimonidine purite 0.15% (Drug); Dorzolamide 2% (Drug); Brinzolamide 1% (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Northwestern Ophthalmic Institute S.C.

Official(s) and/or principal investigator(s):
Thomas E. Bournias, MD, Principal Investigator, Affiliation: Northwestern Ophthalmic Institute S.C.

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.

Clinical Details

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

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

Primary outcome: Intraocular pressure

Eligibility

Minimum age: 41 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Locations and Contacts

Northwestern Ophthalmic Institute S.C., Glenview, Illinois 60026, United States
Additional Information

Starting date: January 2006
Ending date: July 2007
Last updated: May 6, 2008

Page last updated: June 20, 2008

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