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Trial record 77 of 152 for:    Brimonidine

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

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.
ClinicalTrials.gov Identifier: NCT00652483
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : April 3, 2008
Sponsor:
Information provided by:
Allergan

Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: Brimonidine ophthalmic solution 0.1% Drug: Brimonidine ophthalmic solution 0.2% Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 433 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : May 2003
Actual Primary Completion Date : December 2003
Actual Study Completion Date : September 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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®




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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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

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

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