Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients - Full Text View

Sponsored by:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00651612

Purpose

This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution Drug: Concurrent brimonidine 0.2% and 0.5% timolol	Phase III

Genetics Home Reference related topics: early-onset glaucoma

MedlinePlus related topics: Glaucoma High Blood Pressure

Drug Information available for: Brimonidine Brimonidine Tartrate Timolol Timolol maleate

U.S. FDA Resources

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

Further study details as provided by Allergan:

Primary Outcome Measures:

Adverse Events [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

Enrollment:	604
Study Start Date:	November 2005
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution	Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
2: Active Comparator Concurrent Brimonidine 0.2% and 0.5% Timolol	Drug: Concurrent brimonidine 0.2% and 0.5% timolol Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)

Eligibility

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

Criteria

Inclusion Criteria:

Diagnosis of ocular hypertension or glaucoma
Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

Uncontrolled medical conditions
Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651612

Locations

United States, California

Newport Beach, California, 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:	190342-024T
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00651612
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Glaucoma
Eye Diseases
Vascular Diseases
Timolol

Brimonidine
Hypertension
Ocular Hypertension

Additional relevant MeSH terms:

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

Adrenergic Agonists
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents

ClinicalTrials.gov processed this record on January 16, 2009