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Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652106
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 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution Drug: Brimonidine 0.2% ophthalmic solution 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: Day 28 ]

Enrollment: 432
Study Start Date: June 2003
Study Completion Date: March 2004
Primary Completion Date: March 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
Drug: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution
0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
Other Name: COMBIGAN®
Active Comparator: 2
Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
Drug: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution
Brimonidine 0.2% 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and concurrent timolol 0.5% ophthalmic solution 1 drop instilled in each eye twice daily (morning and evening)
Active Comparator: 3
0.2% brimonidine ophthalmic solution
Drug: Brimonidine 0.2% ophthalmic solution
Brimonidine 0.2% ophthalmic solution 1 drop instilled in each eye three times daily (morning, afternoon, and evening)
Other Name: ALPHAGAN®

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Diagnosis of ocular hypertension or glaucoma
  • Patient requires IOP-lowering therapy in both eyes

Exclusion Criteria:

  • Uncontrolled medical conditions
  • Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy
  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): NCT00652106


Locations
United States, Texas
El Paso, Texas, United States
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00652106     History of Changes
Other Study ID Numbers: 190342-019T
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
Timolol
Brimonidine Tartrate
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists