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

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00652106

Purpose

This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution Drug: Brimonidine 0.2% ophthalmic solution	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: Timolol Timolol maleate Brimonidine Brimonidine tartrate

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Intraocular pressure (IOP) [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Enrollment:	432
Study Start Date:	June 2003
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution	Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
2: Active Comparator Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution	Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
3: Active Comparator 0.2% brimonidine ophthalmic solution	Drug: Brimonidine 0.2% ophthalmic solution Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and 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: NCT00652106

Locations

United States, Texas

El Paso, Texas, 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, Inc. ( Therapeutic Area Head )
Study ID Numbers:	190342-019T
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
ClinicalTrials.gov Identifier:	NCT00652106 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
Adrenergic beta-Antagonists
Cardiovascular Diseases
Adrenergic Antagonists
Anti-Arrhythmia Agents
Timolol
Hypertension
Ocular Hypertension
Brimonidine

ClinicalTrials.gov processed this record on February 08, 2010