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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00675207
• Other study ID #: NWOIADJ 2006
• Status: Completed
• Phase: Phase 4
• First received: May 6, 2008
• Last updated: May 6, 2008
• Start date: January 2006
• Est. completion date: July 2007

Study information

• Verified date: May 2008
• Source: Northwestern Ophthalmic Institute S.C.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2007
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 41 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma, Open-Angle
• Ocular Hypertension
• Primary Open Angle Glaucoma

Intervention

Drug:
• Brimonidine purite 0.15%
A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily.
• Dorzolamide 2%
A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily.
• Brinzolamide 1%
A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily.

Locations

Country	Name	City	State
United States	Northwestern Ophthalmic Institute S.C.	Glenview	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern Ophthalmic Institute S.C.	Research to Prevent Blindness

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraocular pressure		Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4	No