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

Study Description

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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 Design

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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

Arms and Interventions

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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™

Outcome Measures

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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.

Eligibility Criteria

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

Criteria

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Allergan

Investigators

Study Director:	Medical Director	Allergan

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Katz LJ, Rauchman SH, Cottingham AJ Jr, Simmons ST, Williams JM, Schiffman RM, Hollander DA. Fixed-combination brimonidine-timolol versus latanoprost in glaucoma and ocular hypertension: a 12-week, randomized, comparison study. Curr Med Res Opin. 2012 May;28(5):781-8. doi: 10.1185/03007995.2012.681036. Epub 2012 Apr 25.

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
Results First Posted:	September 21, 2011
Last Update Posted:	September 21, 2011
Last Verified:	August 2011

Additional relevant MeSH terms:

Hypertension; Glaucoma; Ocular Hypertension; Vascular Diseases; Cardiovascular Diseases; Eye Diseases; Pharmaceutical Solutions; Ophthalmic Solutions; Timolol; Latanoprost; 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