Text Size

A Comfort Study of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01426867
First received: August 24, 2011
Last updated: July 17, 2012
Last verified: December 2011
History of Changes
  Purpose

This is a parallel group, randomized, multicenter study evaluating the comfort of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination, Brinzolamide 1% and Brimonidine 0.2%


Condition Intervention Phase
Open-angle Glaucoma
Ocular Hypertension
 Drug: Brinzolamide / Brimonidine Fixed Combination
Drug: Brinzolamide
Drug: Brimonidine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ocular discomfort of each treatment [ Time Frame: Following approximately 7 days of dosing with treatment ] [ Designated as safety issue: No ]

Enrollment: 101
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brinzolamide / Brimonidine Fixed Combination
Brinzolamide 1% / Brimonidine 0.2% Fixed Combination
 Drug: Brinzolamide / Brimonidine Fixed Combination
Brinzolamide 1% / Brimonidine 0.2% Fixed Combination
Active Comparator: Brinzolamide
Brinzolamide 1%
 Drug: Brinzolamide
Brinzolamide 1%
Active Comparator: Brimonidine
Brimonidine 0.2%
 Drug: Brimonidine
Brimonidine 0.2%

  Eligibility

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

Inclusion Criteria:

  • Patients with a diagnosis of either open angle glaucoma (OAG) or ocular hypertension (OHT) who are currently controlled, in the opinion of the Investigator2) Non-contact lens wearers

Exclusion Criteria:

  • Schaffer angle Grade < 2 as measured by gonioscopy within 1 year of screening visit (extreme narrow angle with complete or partial closure)
  • Patients who are unable to discontinue use of other topical ocular medications, including OTC medications for the duration of the study
  • Any corneal conditions that may be causing significant hyperalgesia or hypoalgesia
  • Acute or chronic ocular allergies (i.e., seasonal allergic conjunctivitis (SAC) and perennial allergic conjunctivitis (PAC))
  • Chronic or recurrent inflammatory ocular disease (i.e., scleritis, uveitis, herpes keratitis)
  • Ocular trauma within the past 6 months
  • Ocular infection or inflammation within the past 3 months
  • Intra-ocular surgery within the past 6 months
  • Ocular laser surgery within the past 3 months
  • Cup/disc ratio > 0.8 (horizontal or vertical measurement)
  • Severe central visual field loss as determined by visual field testing within 6 months of the Screening Visit
  • Hypersensitivity to α-adrenergic agonist drugs, topical or oral carbonic anhydrase inhibitors (CAIs), sulfonamide derivatives, or any component of the study medications in the opinion of the Investigator
  • Patients who were on another investigational agent within 30 days prior to Visit 1
  • History of active, severe, unstable or uncontrolled cardiovascular (e.g. coronary insufficiency, hypertension, Raynaud's phenomenon, orthostatic hypotension, thromboangiitis obliterans), cerebrovascular (e.g. cerebral insufficiency), hepatic, or renal disease that would preclude the safe administration of a topical α-adrenergic agonist or CAI in the opinion of the investigator
  • History of or current evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
  • Patients with recent (within 4 weeks of the Screening Visit) use of high-dose (>1 g daily) salicylate therapy
  • Concurrent use of monoamine oxidase inhibitors (MAOI)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01426867

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: NCT01426867     History of Changes
Other Study ID Numbers: C-11-002
Study First Received: August 24, 2011
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Alcon Research:
Glaucoma
intraocular pressure

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