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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00811564
Recruitment Status : Completed
First Posted : December 19, 2008
Results First Posted : September 21, 2011
Last Update Posted : September 21, 2011
Information provided by:

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution Drug: latanoprost 0.005% Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Study Start Date : December 2008
Primary Completion Date : January 2010
Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
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™

Primary Outcome Measures :
  1. Intraocular Pressure (IOP) at Week 12 [ Time Frame: Week 12 ]
    Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be at least 18 years of age;
  2. Give written informed consent;
  3. Be in good general health as determined by your doctor;
  4. Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension;
  5. 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);
  6. Understand the study instructions, and be able to follow the study instructions; and
  7. Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits.

Exclusion Criteria:

  1. Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation;
  2. 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
  3. Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00811564

United States, New York
Slingerlands, New York, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Affairs Director, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00811564     History of Changes
Other Study ID Numbers: GMA-COM-08-008
First Posted: December 19, 2008    Key Record Dates
Results First Posted: September 21, 2011
Last Update Posted: September 21, 2011
Last Verified: August 2011

Additional relevant MeSH terms:
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Brimonidine Tartrate
Maleic acid
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Enzyme Inhibitors
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists