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 has been completed.
Sponsor:
Allergan
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00811564
First received: December 17, 2008
Last updated: August 17, 2011
Last verified: August 2011
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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 4 |
| 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:
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
More Information
No publications provided by Allergan
Additional 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 |
| 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 May 19, 2013