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

Sponsor:	Northwestern Ophthalmic Institute S.C.
Collaborator:	Research to Prevent Blindness
Information provided by:	Northwestern Ophthalmic Institute S.C.
ClinicalTrials.gov Identifier:	NCT00675207

Purpose

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.

Condition	Intervention	Phase
Primary Open Angle Glaucoma Ocular Hypertension	Drug: Brimonidine purite 0.15% Drug: Dorzolamide 2% Drug: Brinzolamide 1%	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Comparison of Brimonidine 0.15% Purite, Dorzolamide 2%, and Brinzolamide 1% as Adjunctive Therapy to Prostaglandin Analogs

Resource links provided by NLM:

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Brimonidine Brimonidine tartrate Dorzolamide Dorzolamide hydrochloride Azopt

U.S. FDA Resources

Further study details as provided by Northwestern Ophthalmic Institute S.C.:

Primary Outcome Measures:

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 ]

Enrollment:	120
Study Start Date:	January 2006
Study Completion Date:	July 2007
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Brimonidine purite 0.15%	Drug: Brimonidine purite 0.15% A single drop of brimonidine purite 0.15% ophthalmic solution administered topically in the eye 3 times daily. Other Name: Alphagan P 0.15%
Active Comparator: 2 Dorzolamide 2%	Drug: Dorzolamide 2% A single drop of dorzolamide 2% ophthalmic solution administered topically in the eye 3 times daily. Other Name: Trusopt
Active Comparator: 3 Brinzolamide 1%	Drug: Brinzolamide 1% A single drop of brinzolamide 1% ophthalmic solution administered topically in the eye 3 times daily. Other Name: Azopt

Eligibility

Ages Eligible for Study:	41 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00675207

Locations

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

Sponsors and Collaborators

Northwestern Ophthalmic Institute S.C.

Research to Prevent Blindness

Investigators

Principal Investigator:

Thomas E. Bournias, MD

Northwestern Ophthalmic Institute S.C.

More Information

No publications provided

Responsible Party:	Thomas E. Bournias, Northwestern Ophthalmic Institute S.C.
ClinicalTrials.gov Identifier:	NCT00675207 History of Changes
Other Study ID Numbers:	NWOIADJ 2006
Study First Received:	May 6, 2008
Last Updated:	May 6, 2008
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern Ophthalmic Institute S.C.:

glaucoma
ocular hypertension
adjunctive treatment
prostaglandin
prostaglandin analog
brimonidine

dorzolamide
brinzolamide
alpha agonist
carbonic anhydrase inhibitor
intraocular pressure

Additional relevant MeSH terms:

Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Carbonic Anhydrase Inhibitors
Dorzolamide
Brinzolamide
Brimonidine
Enzyme Inhibitors

Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012