This study evaluates the safety of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Study Type: Interventional

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

Study Primary Completion Date: January 2007

Intervention(s) in this Clinical Trial

• Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
  • Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
• Drug: Concurrent brimonidine 0.2% and 0.5% timolol
  • Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
• Active Comparator: 2
  • Concurrent Brimonidine 0.2% and 0.5% Timolol

Primary Measures

• Adverse Events
  • Time Frame: Day 10
    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 September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00651612

Study ID Number: 190342-024T

ClinicalTrials.gov Identifier: NCT00651612

Health Authority: United States: Food and Drug Administration

Link to Clinical Trial Results