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Study to Evaluate Safety of Brimonidine/Timolol Fixed Combination in Glaucoma or Ocular Hypertension Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00651612
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 of brimonidine/timolol fixed combination in glaucoma or ocular hypertension patients

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution Drug: Concurrent brimonidine 0.2% and 0.5% timolol 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:
  • Adverse Events [ Time Frame: Day 10 ]

Enrollment: 604
Study Start Date: November 2005
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
Drug: Brimonidine 0.2%/Timolol 0.5% Fixed Combination Ophthalmic Solution
Brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution 1 drop instilled in each eye two times daily (morning and evening)
Other Name: COMBIGAN™
Active Comparator: 2
Concurrent Brimonidine 0.2% and 0.5% Timolol
Drug: Concurrent brimonidine 0.2% and 0.5% timolol
Brimonidine 0.2%, 1 drop instilled in each eye three times daily (morning, afternoon, and evening) and timolol 0.5% timolol, 1 drop instilled in each eye twice daily (morning and evening) and vehicle of brimonidine combination ophthalmic solution 1 drop instilled in each eye (morning, afternoon and/or evening)

  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): NCT00651612


Locations
United States, California
Newport Beach, California, 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: NCT00651612     History of Changes
Other Study ID Numbers: 190342-024T
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