An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects - Full Text View

Sponsor:	Allergan
Information provided by:	Allergan
ClinicalTrials.gov Identifier:	NCT00811564

Purpose

A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects

Condition	Intervention	Phase
Glaucoma Ocular Hypertension	Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution Drug: latanoprost 0.005%	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (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 Latanoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

Intraocular Pressure (IOP) at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.

Enrollment:	148
Study Start Date:	December 2008
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution	Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day Other Name: Combigan™
Active Comparator: 2 Latanoprost 0.005% ophthalmic solution	Drug: latanoprost 0.005% 1 drop of study medication taken once daily Other Name: Xalatan™

Eligibility

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

Criteria

Inclusion Criteria:

Be at least 18 years of age;
Give written informed consent;
Be in good general health as determined by your doctor;
Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills);
Understand the study instructions, and be able to follow the study instructions; and
Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and
Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00811564

Locations

United States, New York

Slingerlands, New York, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Medical Affairs Director, Allergan, Inc.
ClinicalTrials.gov Identifier:	NCT00811564 History of Changes
Other Study ID Numbers:	GMA-COM-08-008
Study First Received:	December 17, 2008
Results First Received:	August 17, 2011
Last Updated:	August 17, 2011
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Timolol
Brimonidine
Latanoprost
Maleic acid
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
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on February 09, 2012