Brimonidine 0.1% Versus Brinzolamide 1% as Adjunctive Therapy to Latanoprost 0.005% - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00440141

Purpose

Patients with glaucoma or ocular hypertension currently being treated with latanoprost 0.005%, and in need of additional IOP lowering will be randomized to receive either brimonidine 0.1% or brinzolamide 1% three-times daily as adjunctive therapy to latanoprost 0.005%

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops	Phase IV

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Brimonidine Brimonidine Tartrate Latanoprost Tetrahydrozoline Tetrahydrozoline hydrochloride Azopt

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

IOP [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Tolerability [ Time Frame: Month 3 ] [ Designated as safety issue: No ]

Enrollment:	40
Study Start Date:	July 2006
Study Completion Date:	March 2007
Primary Completion Date:	March 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: latanoprost 0.005% eye drops and brimonidine 0.1% eye drops latanoprost 0.005%, 1 drop nightly for 3 months and brimonidine 0.1% three-times daily for 3 months
2: Active Comparator	Drug: latanoprost 0.005% eye drops and brinzolamide 1.0% eye drops latanoprost 0.005% 1 drop nightly for 3 months AND brinzolamide 1.0% 1% three-times daily for 3 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Glaucoma or ocular hypertension in both eyes
Currently being treated with latanoprost 0.005% QD
IOP greater than or equal to 18mm Hg on latanoprost 0.005%
Best-corrected VA of 20/200 or better in each eye
Visual field within 6 months of study entry

Exclusion Criteria:

Secondary glaucoma
Active intraocular inflammation or macular edema
Intraocular surgery or laser surgery within the past 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00440141

Locations

United States, Georgia

Atlanta, Georgia, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Affairs

Allergan

More Information

Publications indexed to this study:

Day DG, Hollander DA. Brimonidine purite 0.1% versus brinzolamide 1% as adjunctive therapy to latanoprost in patients with glaucoma or ocular hypertension. Curr Med Res Opin. 2008 May;24(5):1435-42. Epub 2008 Apr 9.

Responsible Party:	Allergan, Inc. ( Therapeutic Area Head )
Study ID Numbers:	MA-AP01
Study First Received:	February 22, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00440141
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Pseudoephedrine
Brinzolamide
Eye Diseases
Vascular Diseases
Tetrahydrozoline
Latanoprost
Naphazoline
Oxymetazoline

Guaifenesin
Glaucoma
Phenylephrine
Ephedrine
Phenylpropanolamine
Ocular Hypertension
Hypertension
Brimonidine

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Sympathomimetics
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents

Pharmacologic Actions
Adrenergic Agonists
Nasal Decongestants
Carbonic Anhydrase Inhibitors
Autonomic Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009