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| Sponsor: | Allergan |
|---|---|
| Information provided by: | Allergan |
| ClinicalTrials.gov Identifier: | NCT00735449 |
Purpose
Efficacy and safety evaluation of Combigan with timolol when each is used as adjunctive therapy to Xalatan in subjects with glaucoma or ocular hypertension.
| Condition | Intervention | Phase |
|---|---|---|
|
Glaucoma Ocular Hypertension |
Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution Drug: timolol maleate 0.5% |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Investigator), Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparing Efficacy and Safety of Combigan With Timolol Adjunctive to Xalatan in Glaucoma or Ocular Hypertension Subjects |
| Estimated Enrollment: | 200 |
| Study Start Date: | July 2008 |
| Estimated Study Completion Date: | February 2010 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
Combigan adjunctive to Xalatan
|
Drug: Fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
1 drop of study medication taken approximately 12 hours apart, up to 2 times a day
|
|
2: Active Comparator
Timolol adjunctive to Xalatan
|
Drug: timolol maleate 0.5%
1 drop of study medication taken approximately 12 hours apart, up to 2 times a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Allergan Inc | clinicaltrials@allergan.com |
| United States, New Jersey | |
| Recruiting | |
| Newark, New Jersey, United States | |
| Canada, Quebec | |
| Recruiting | |
| Montreal, Quebec, Canada | |
| Study Director: | Medical Director | Allergan |
More Information
| Responsible Party: | Allergan, Inc. ( Vice President Medical Affairs ) |
| Study ID Numbers: | GMA-COM-07-XTC |
| Study First Received: | August 13, 2008 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00735449 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Neurotransmitter Agents Adrenergic alpha-Agonists Adrenergic Agents Molecular Mechanisms of Pharmacological Action Eye Diseases Physiological Effects of Drugs Vascular Diseases Cardiovascular Agents Antihypertensive Agents Adrenergic Agonists Pharmacologic Actions |
Glaucoma Therapeutic Uses Adrenergic beta-Antagonists Cardiovascular Diseases Adrenergic Antagonists Anti-Arrhythmia Agents Timolol Hypertension Ocular Hypertension Brimonidine |