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
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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 |
Actual Primary Completion Date : | January 2010 |
Actual Study Completion Date : | January 2010 |

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™ |
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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 |
Study Director: | Medical Director | Allergan |
Responsible Party: | Medical Affairs Director, Allergan, Inc. |
ClinicalTrials.gov Identifier: | NCT00811564 |
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 |
Glaucoma Ocular Hypertension Hypertension Vascular Diseases Cardiovascular Diseases Eye Diseases Timolol Brimonidine Tartrate Ophthalmic Solutions Latanoprost Pharmaceutical Solutions |
Adrenergic beta-Antagonists Adrenergic Antagonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anti-Arrhythmia Agents Antihypertensive Agents Adrenergic alpha-2 Receptor Agonists Adrenergic alpha-Agonists Adrenergic Agonists |