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

Tracking Information

First Received Date ^ICMJE

May 6, 2008

Last Updated Date

May 6, 2008

Start Date ^ICMJE

January 2006

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraocular pressure [ Time Frame: Measurements at peak and trough effect (10 am and 4 pm) at baseline, month 1, and month 4 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Primary Open Angle Glaucoma
Ocular Hypertension

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: Brimonidine purite 0.15%
Active Comparator: Dorzolamide 2%
Active Comparator: Brinzolamide 1%

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

July 2007

Primary Completion Date

July 2007 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

41 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00675207

Responsible Party

Thomas E. Bournias, Northwestern Ophthalmic Institute S.C.

Study ID Numbers ^ICMJE

NWOIADJ 2006

Study Sponsor ^ICMJE

Northwestern Ophthalmic Institute S.C.

Collaborators ^ICMJE

Research to Prevent Blindness

Investigators ^ICMJE

Principal Investigator:

Thomas E. Bournias, MD

Northwestern Ophthalmic Institute S.C.

Information Provided By

Northwestern Ophthalmic Institute S.C.

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP