This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: March 2004

Intervention(s) in this Clinical Trial

• Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
  • 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
• Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
  • Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
• Drug: Brimonidine 0.2% ophthalmic solution
  • Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
• Active Comparator: 2
  • Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
• Active Comparator: 3
  • 0.2% brimonidine ophthalmic solution

Primary Measures

• Intraocular pressure (IOP)
  • Time Frame: Day 28
    Safety Issue?: No

Inclusion Criteria:

• Diagnosis of ocular hypertension or glaucoma
• Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

• Uncontrolled medical conditions
• Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Allergan

Overall Clinical Trial Officials and Contacts

Medical Director Study Director Allergan  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00652106

Study ID Number: 190342-019T

ClinicalTrials.gov Identifier: NCT00652106

Health Authority: United States: Food and Drug Administration

Link to Clinical Trial Results