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

This study is currently recruiting participants.

Verified by Allergan, June 2009

First Received: December 17, 2008 Last Updated: June 4, 2009 History of Changes

Sponsored by:	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:	Treatment, Randomized, Single Blind (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 Latanoprost

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:

IOP [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse Events [ Time Frame: Baseline, Week 6 and Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	165
Study Start Date:	December 2008
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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
2: Active Comparator Latanoprost 0.005% ophthalmic solution	Drug: latanoprost 0.005% 1 drop of study medication taken once daily

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

Contacts

Contact: Allergan Inc

clinicaltrials@allergan.com

Locations

United States, New York
	Recruiting
Slingerlands, New York, United States

Sponsors and Collaborators

Allergan

Investigators

Study Director:

Medical Director

Allergan

More Information

No publications provided

Responsible Party:	Allergan, Inc. ( Medical Affairs Director )
Study ID Numbers:	GMA-COM-08-008
Study First Received:	December 17, 2008
Last Updated:	June 4, 2009
ClinicalTrials.gov Identifier:	NCT00811564 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Adrenergic Agents
Eye Diseases
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
Adrenergic Agonists

Glaucoma
Adrenergic beta-Antagonists
Adrenergic Antagonists
Timolol
Anti-Arrhythmia Agents
Ocular Hypertension
Hypertension
Brimonidine

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic alpha-Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Eye Diseases
Physiological Effects of Drugs
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Latanoprost
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 September 03, 2009