Safety and Efficacy of Adding Azarga Adjunctive to Prostaglandin Therapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01263444
First received: December 17, 2010
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to evaluate the safety and efficacy of adding AZARGA® as a single agent to prostaglandin monotherapy in patients with either ocular hypertension or primary open-angle glaucoma.


Condition Intervention Phase
Glaucoma
Drug: Brinzolamide/Timolol 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:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Intraocular Pressure (IOP) change from baseline at Month 3. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    All IOP measurements will be performed with a Goldmann applanation tonometer.


Enrollment: 47
Study Start Date: March 2011
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Azarga
Azarga added to current prostaglandin therapy (historical control)
Drug: Brinzolamide/Timolol Maleate Fixed Combination (Azarga)
Brinzolamide/Timolol Maleate Fixed Combination administered as 1 drop in treated eye(s) twice daily for 3 months in addition to current prostaglandin therapy.
Other Name: Azarga

  Eligibility

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

Inclusion Criteria:

  • Must be 18 years of age or older.
  • Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
  • At Screening/baseline visit, must have an IOP of ≥ 20 millimeters mercury (mm Hg) in at least one eye and ≤ 35 mm Hg in both eyes treated with prostaglandin monotherapy.
  • In any eye not qualifying as a study eye, the intraocular pressure should be able to be controlled on no pharmacologic therapy or on prostaglandin monotherapy alone.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Known medical history of allergy, hypersensitivity or poor tolerance to any component of Azarga® that is deemed clinically significant in the opinion of the investigator.
  • Corneal dystrophies in either eye
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
  • Bronchial asthma or a history of bronchial asthma, bronchial hyper reactivity, or severe chronic obstructive pulmonary disease that would preclude the safe administration of a topical beta-blocker.
  • History of severe allergic rhinitis.
  • A condition, which in the opinion of the principal investigator, would interfere with optimal participation in the study, or which would present a special risk to the subject.
  • Participation in any other investigational study within 30 days prior to the screening/baseline visit.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01263444     History of Changes
Other Study ID Numbers: RDG-10-246, 2010-022948-21
Study First Received: December 17, 2010
Last Updated: May 2, 2013
Health Authority: France: Committee for the Protection of Personnes
Austria: Ethikkommission
Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Maleic acid
Brinzolamide
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Antihypertensive Agents
Enzyme Inhibitors
Carbonic Anhydrase Inhibitors

ClinicalTrials.gov processed this record on April 22, 2014