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Three Month Efficacy/Safety Study With a 3 Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01297920
First received: February 15, 2011
Last updated: June 1, 2012
Last verified: June 2012
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% or brimonidine 0.2%.


Condition Intervention Phase
Open Angle Glaucoma
Ocular Hypertension
 Drug: Brinzolamide 1% / Brimonidine Tartrate 0.2%
Drug: Brinzolamide ophthalmic suspension, 1%
Drug: Brimonidine Tartrate 0.2%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Three Month Efficacy/Safety Study With a 3 Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% Fixed Combination TID vs. Brinzolamide 1% TID or Brimonidine 0.2% TID

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Efficacy:Mean Intraocular Pressure [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 690
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brinzolamide 1% / Brimonidine Tartrate 0.2%
Brinzolamide 1% / Brimonidine Tartrate 0.2% ophthalmic suspension, fixed combination
 Drug: Brinzolamide 1% / Brimonidine Tartrate 0.2%
Eye Drops Suspension, one drop in each eye three times a day
Active Comparator: Brinzolamide ophthalmic suspension, 1%
Brinzolamide ophthalmic suspension, 1%
 Drug: Brinzolamide ophthalmic suspension, 1%
Eye Drops Suspension, one drop in each eye three times a day
Active Comparator: Brimonidine Tartrate 0.2%
Brimonidine Tartrate 0.2%, ophthalmic solution
 Drug: Brimonidine Tartrate 0.2%
Eye Drops Suspension, one drop in each eye three times a day

  Eligibility

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

Inclusion Criteria:

  • Patients diagnosed with open-angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Patients with any form of glaucoma other than open-angle glaucoma.
  • Patients with a central cornea thickness greater than 620 μm
  • Patients with Schaffer angle Grade < 2
  • Patients with a cup/disc ratio greater than 0.80
  • Patients with severe central visual field loss
  • Best-Corrected Visual Acuity 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: NCT01297920

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: NCT01297920     History of Changes
Other Study ID Numbers: C-10-039
Study First Received: February 15, 2011
Last Updated: June 1, 2012
Health Authority: United States: Food and Drug Administration

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 16, 2013