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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00652483
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • IOP [ Time Frame: Month 6 - Month 12 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652483

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

Additional Information:
No publications provided

Responsible Party: Therapeutic Area Head, Allergan
ClinicalTrials.gov Identifier: NCT00652483     History of Changes
Other Study ID Numbers: 190342-021
Study First Received: April 1, 2008
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Brimonidine
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Cardiovascular Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014