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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:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00652106
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 0.2%/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
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: Day 28 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT00652106

Locations
United States, Texas
El Paso, Texas, 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, Inc.
ClinicalTrials.gov Identifier: NCT00652106     History of Changes
Other Study ID Numbers: 190342-019T
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
Timolol
Adrenergic Agents
Adrenergic Agonists
Adrenergic Antagonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
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 20, 2014