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Safety and Efficacy Study of Brimonidine in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Information provided by:
Allergan Identifier:
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
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

Condition Intervention Phase
Ocular Hypertension
Drug: Brimonidine ophthalmic solution 0.1%
Drug: Brimonidine ophthalmic solution 0.2%
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Intraocular pressure (IOP) [ Time Frame: Week 2 - Month 3 ]

Secondary Outcome Measures:
  • IOP [ Time Frame: Month 6 - Month 12 ]

Enrollment: 433
Study Start Date: May 2003
Study Completion Date: September 2004
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Brimonidine ophthalmic solution 0.1%
Drug: Brimonidine ophthalmic solution 0.1%
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Active Comparator: 2
Brimonidine ophthalmic solution 0.2%
Drug: Brimonidine ophthalmic solution 0.2%
1 drop instilled in each eye 3 times daily (08:00, 14:00, 20:00)
Other Name: ALPHAGAN®


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

Inclusion Criteria:

  • Ocular hypertension or glaucoma in both eyes

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Known allergy or sensitivity to brimonidine
  Contacts and Locations
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Please refer to this study by its identifier: NCT00652483

United States, Georgia
Atlanta, Georgia, United States
Sponsors and Collaborators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Allergan Identifier: NCT00652483     History of Changes
Other Study ID Numbers: 190342-021
Study First Received: April 1, 2008
Last Updated: April 1, 2008

Additional relevant MeSH terms:
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Brimonidine Tartrate
Ophthalmic Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 25, 2017