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Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00961649
First received: August 18, 2009
Last updated: July 17, 2012
Last verified: March 2010
History of Changes
  Purpose

The purpose of the study is to determine whether combination of brinzolamide and brimonidine is safe and effective in patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: brinzolamide/brimonidine
Drug: brinzolamide
Drug: brimonidine
Drug: brinzolamide + brimonidine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP [ Time Frame: 8 AM, 10 AM, 3 PM, 5 PM ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Visual acuity [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]
  • Ocular Signs [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]
  • Fundus Parameters [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]
  • Pulse/Blood Pressure [ Time Frame: 8 AM ] [ Designated as safety issue: Yes ]

Enrollment: 170
Study Start Date: November 2009
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
brinzolamide/brimonidine combination
 Drug: brinzolamide/brimonidine
Effect of brinzolamide/brimonidine on IOP
Active Comparator: 2
brinzolamide
 Drug: brinzolamide
Effect of brinzolamide on IOP
Active Comparator: 3
brimonidine
 Drug: brimonidine
Effect of brimonidine on IOP
Active Comparator: 4
brinzolamide + brimonidine
 Drug: brinzolamide + brimonidine
Effect of brinzolamide + brimonidine on IOP

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients 18 years of age or older, of either sex and of any race diagnosed with open-angle glaucoma or ocular hypertension.

Exclusion Criteria:

  • Any form of glaucoma other than open-angle glaucoma
  • angle grade less than Grade 2
  • cup/disc ratio greater than 0.80
  • severe central visual field loss
  • chronic, recurrent or severe eye conditions
  • anticipated/current use of contraindicated medications
  • severe systemic conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961649

Locations
United States, Texas
Contact Alcon Call Center For Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00961649     History of Changes
Other Study ID Numbers: C-09-038
Study First Received: August 18, 2009
Last Updated: July 17, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
Open-angle glaucoma
ocular hypertension
brinzolamide
brimonidine

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Brimonidine
Brinzolamide
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
 Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013