This study evaluates the safety and efficacy of brimonidine 0.1% ophthalmic solution compared with brimonidine 0.2% ophthalmic solution in patients with glaucoma or ocular hypertension

Study Type: Interventional

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

Study Primary Completion Date: December 2003

Intervention(s) in this Clinical Trial

• Drug: Brimonidine ophthalmic solution 0.1%
  • 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
• Drug: Brimonidine ophthalmic solution 0.2%
  • 1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Brimonidine ophthalmic solution 0.1%
• Active Comparator: 2
  • Brimonidine ophthalmic solution 0.2%

Primary Measures

• Intraocular pressure (IOP)
  • Time Frame: Week 2 - Month 3
    Safety Issue?: No

Secondary Measures

• IOP
  • Time Frame: Month 6 - Month 12
    Safety Issue?: No

Inclusion Criteria:

• Ocular hypertension or glaucoma in both eyes

Exclusion Criteria:

• Uncontrolled systemic disease
• Known allergy or sensitivity to brimonidine

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/NCT00652483

Study ID Number: 190342-021

ClinicalTrials.gov Identifier: NCT00652483

Health Authority: United States: Food and Drug Administration

Link to Clinical Trial Results