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Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

This study is currently recruiting participants.
Verified May 2013 by Alcon Research
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01415401
First received: August 10, 2011
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension who have uncontrolled intraocular pressure (IOP).


Condition Intervention Phase
Glaucoma
 Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combination (AZARGA®)
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in intraocular pressure at final visit from prior brimonidine 0.2%/timolol 0.5% (COMBIGAN®) therapy (i.e., baseline). [ Time Frame: 8 Weeks ] [ Designated as safety issue: Yes ]
    Goldmann applanation tonometry will be performed at the baseline visit and at the 8-week visit to record intraocular pressure. Change at 8 weeks from baseline will be calculated. IOP will be measured in mmHg.


Secondary Outcome Measures:
  • Percentage of subjects who reach target IOP (≤ 18 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    Goldmann applanation tonometry will be performed at the 8-week visit to record intraocular pressure. Percentage of patients who reach target IOP will be calculated.


Estimated Enrollment: 54
Study Start Date: October 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZARGA
One drop self-administered in study eye(s) twice daily for 8 weeks
 Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combination (AZARGA®)
Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension
Other Name: AZARGA®

  Eligibility

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

Inclusion Criteria:

  • 18 years or older.
  • Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
  • Be on a stable IOP lowering regimen within 30 days of Screening Visit.
  • IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
  • Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
  • IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
  • Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known history of hypersensitivity to any component of the preparations used in this study.
  • Presence of primary or secondary glaucoma not listed in inclusion criterion #2.
  • History of ocular herpes simplex.
  • Abnormality preventing reliable applanation tonometry
  • Corneal dystrophies.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
  • Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
  • Progressive retinal or optic nerve disease from any cause.
  • Women of childbearing potential not using reliable means of birth control for at least one month prior to the Screening/Baseline Visit.
  • Pregnant or lactating.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01415401

Contacts
Contact: Alcon Call Center 1-888-451-3937 medical.information@alconlabs.com

Locations
Canada
Contact Alcon Call Center for Trial Locations Recruiting
Ontario, Canada, L2A 1Z3
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01415401     History of Changes
Other Study ID Numbers: RDG-11-199
Study First Received: August 10, 2011
Last Updated: May 2, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Alcon Research:
Glaucoma
Intraocular hypertension
Intraocular pressure (IOP)

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Maleic acid
Brinzolamide
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Carbonic Anhydrase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013