Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00966576
Recruitment Status : Completed
First Posted : August 27, 2009
Last Update Posted : November 21, 2016
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 47 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy
Study Start Date : July 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Brinzolamide/Timolol Maleate Fixed Combination Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)
1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks
Other Name: AZARGA

Primary Outcome Measures :
  1. The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success [ Time Frame: Week 4 and Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Sign Informed Consent.
  • 21 years of age or older.
  • Able to follow instructions and willing to attend required study visits.
  • Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye).
  • Intra-ocular pressure (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 trial.
  • Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Presence of other primary or secondary glaucomas not listed in inclusion criterion.
  • Presence of corneal dystrophies.
  • Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
  • Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment.
  • Women of childbearing potential not using reliable means of birth control.
  • Women who are pregnant or lactating.
  • Participation in any other investigational study within 30 days prior to Visit 1.
  • Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial.
  • Severe allergic rhinitis
  • History of ocular herpes simplex.
  • Other protocol-defined exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00966576

Mainz, Germany, 55101
Sponsors and Collaborators
Alcon Research

Publications of Results:
Responsible Party: Alcon Research Identifier: NCT00966576     History of Changes
Other Study ID Numbers: SMA-08-22a
First Posted: August 27, 2009    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: April 2012

Keywords provided by Alcon Research:

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