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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00651612
First received: April 1, 2008
Last updated: NA
Last verified: April 2008
History: No changes posted
  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
Endpoint Classification: Safety 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:
  • Adverse Events [ Time Frame: Day 10 ] [ Designated as safety issue: No ]

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

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: NCT00651612

Locations
United States, California
Newport Beach, California, 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
ClinicalTrials.gov Identifier: NCT00651612     History of Changes
Other Study ID Numbers: 190342-024T
Study First Received: April 1, 2008
Last Updated: April 1, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hypertension
Ocular Hypertension
Glaucoma
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Timolol
Brimonidine
Ophthalmic Solutions
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists

ClinicalTrials.gov processed this record on September 22, 2014