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

Sponsor:	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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), 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

U.S. FDA Resources

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

Additional Information:

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

No publications provided

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 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents

Adrenergic Agonists
Pharmacologic Actions
Glaucoma
Therapeutic Uses
Cardiovascular Diseases
Hypertension
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on February 08, 2010