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

Sponsor:	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

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

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 Tetrahydrozoline Latanoprost Azopt Tetrahydrozoline hydrochloride

U.S. FDA Resources

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

No publications provided by Allergan

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tetrahydrozoline
Adrenergic Agonists
Nasal Decongestants
Glaucoma
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Diseases
Adrenergic alpha-Agonists
Sympathomimetics

Brinzolamide
Eye Diseases
Vascular Diseases
Enzyme Inhibitors
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Pharmacologic Actions
Carbonic Anhydrase Inhibitors
Autonomic Agents
Peripheral Nervous System Agents
Brimonidine
Ocular Hypertension
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010