Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00652483

Purpose

This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: Brimonidine ophthalmic solution 0.1% Drug: Brimonidine ophthalmic solution 0.2%	Phase III

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Further study details as provided by Allergan:

Primary Outcome Measures:

Intraocular pressure (IOP) [ Time Frame: Week 2 - Month 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

IOP [ Time Frame: Month 6 - Month 12 ] [ Designated as safety issue: No ]

Enrollment:	433
Study Start Date:	May 2003
Study Completion Date:	September 2004
Primary Completion Date:	December 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Brimonidine ophthalmic solution 0.1%	Drug: Brimonidine ophthalmic solution 0.1% 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
2: Active Comparator Brimonidine ophthalmic solution 0.2%	Drug: Brimonidine ophthalmic solution 0.2% 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

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

Exclusion Criteria:

Uncontrolled systemic disease
Known allergy or sensitivity to brimonidine

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652483

Locations

United States, Georgia

Atlanta, Georgia, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

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

Responsible Party:	Allergan ( Therapeutic Area Head )
Study ID Numbers:	190342-021
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00652483
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Vascular Diseases

Brimonidine
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Pharmacologic Actions
Adrenergic Agonists

ClinicalTrials.gov processed this record on January 16, 2009