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

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ClinicalTrials.gov Identifier: NCT00652106
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 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
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®




Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: Day 28 ]


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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:

  • 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

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

Additional Information:
Responsible Party: Therapeutic Area Head, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00652106     History of Changes
Other Study ID Numbers: 190342-019T
First Posted: April 3, 2008    Key Record Dates
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