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

Sponsor:	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) 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: Timolol Timolol maleate Brimonidine Brimonidine tartrate

U.S. FDA Resources

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
Experimental: 1 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) Other Name: COMBIGAN™
Active Comparator: 2 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

Additional Information:

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

No publications provided

Responsible Party:	Therapeutic Area Head, Allergan
ClinicalTrials.gov Identifier:	NCT00651612 History of Changes
Other Study ID Numbers:	190342-024T
Study First Received:	April 1, 2008
Last Updated:	April 1, 2008
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on February 09, 2012