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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652483
First Posted: April 3, 2008
Last Update Posted: April 3, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
  Purpose
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
Glaucoma 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 (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®

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Ocular hypertension or glaucoma in both eyes

Exclusion Criteria:

  • Uncontrolled systemic disease
  • Known allergy or sensitivity to brimonidine
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652483


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

Additional Information:
Responsible Party: Therapeutic Area Head, Allergan
ClinicalTrials.gov Identifier: NCT00652483     History of Changes
Other Study ID Numbers: 190342-021
First Submitted: April 1, 2008
First Posted: April 3, 2008
Last Update Posted: April 3, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Brimonidine Tartrate
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


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