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Efficacy and Safety of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination BID vs. Brinzolamide 1% BID Plus Brimonidine 0.2% BID

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01309204
First received: March 3, 2011
Last updated: February 25, 2013
Last verified: February 2013
History of Changes
  Purpose

A multi-center, double-masked, randomized parallel group efficacy and safety study of brinzolamide 1% /brimonidine 0.2% fixed combination compared to brinzolamide 1% plus brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension.


Condition Intervention Phase
Open-angle Glaucoma or Ocular Hypertension
 Drug: Brinzolamide 1% / brimonidine 0.2% ophthalmic suspension
Other: Vehicle for masking purposes
Drug: Brinzolamide 1% ophthalmic suspension (AZOPT)
Drug: Brimonidine 0.2% ophthalmic solution
 Phase 3

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:
  • Efficacy: mean diurnal IOP (average over time points) change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 1184
Study Start Date: May 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brinzolamide 1%/Brimonidine
Brinzolamide 1%/Brimonidine 0.2% fixed combination
 Drug: Brinzolamide 1% / brimonidine 0.2% ophthalmic suspension
Eye drops, suspension - one drop in each eye twice a day
Other: Vehicle for masking purposes
Eye drops, solution - one drop in each eye, two times a day
Active Comparator: Brinzolamide 1% plus Brimonidine 0.2%
Brinzolamide 1% plus Brimonidine 0.2% concomitant administration
 Drug: Brinzolamide 1% ophthalmic suspension (AZOPT)
Eye drops, suspension - one drop in each eye, two times a day
Other Name: AZOPT
Drug: Brimonidine 0.2% ophthalmic solution
Eye drops, solution - one drop in each eye, twice a day

  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 gender, and any race/ethnicity, diagnosed with open-angle glaucoma or ocular hypertension who in the opinion of the Investigator are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
  • Patients meeting qualifying IOP entry criteria.
  • Able to understand and sign an informed consent form that has been approved by an Institutional Review Board/Independent Ethics Committee.

Exclusion Criteria:

  • Schaffer angle Grade < 2
  • Cup/disc ratio greater than 0.80
  • Severe central visual field loss
  • Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent)
  • Chronic, recurrent or severe inflammatory eye disease
  • Clinically significant or progressive retinal disease
  • Other ocular pathology
  • Patients with recent use of high-dose (>1 gm daily) salicylate therapy
  • Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01309204

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: NCT01309204     History of Changes
Other Study ID Numbers: C-10-041, 2010-024513-31
Study First Received: March 3, 2011
Last Updated: February 25, 2013
Health Authority: European Union: European Medicines Agency
Australia: Department of Health and Ageing Therapeutic Goods Administration
Argentina: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
Colombia: National Institutes of Health
Hong Kong: Department of Health
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Philippines: Department of Health

Keywords provided by Alcon Research:
open-angle glaucoma
ocular hypertension
OAG
OHT

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