Safety and Efficacy of Brimonidine in Patients With Glaucoma or Ocular Hypertension

This study has been completed.

First Received on September 12, 2005. Last Updated on May 27, 2011 History of Changes

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00168363

Purpose

This Study will evaluate the safety and efficacy of brimonidine in patients with glaucoma or ocular hypertension

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: brimonidine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment

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

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

lowering of intraocular pressure

Enrollment:	207
Study Start Date:	January 2005
Study Completion Date:	August 2006
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

ocular hypertension or glaucoma in both eyes
currently treated with brimonidine
requires IOP-lowering therapy in both eyes

Exclusion Criteria:

uncontrolled systemic disease
known allergy or sensitivity to brimonidine

Contacts and Locations

No Contacts or Locations Provided

More Information

Additional Information:

Link to Clinical Trial Results This link exits the ClinicalTrials.gov site

No publications provided by Allergan

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cantor LB, Safyan E, Liu CC, Batoosingh AL. Brimonidine-purite 0.1% versus brimonidine-purite 0.15% twice daily in glaucoma or ocular hypertension: a 12-month randomized trial. Curr Med Res Opin. 2008 Jul;24(7):2035-43. Epub 2008 Jun 4.

Responsible Party:	Therapeutic Area Head, Allergan, Inc
ClinicalTrials.gov Identifier:	NCT00168363 History of Changes
Other Study ID Numbers:	190342-022
Study First Received:	September 12, 2005
Last Updated:	May 27, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brimonidine
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists

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

ClinicalTrials.gov processed this record on February 09, 2012