Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00966576
First received: August 26, 2009
Last updated: July 18, 2012
Last verified: April 2012
  Purpose

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 Intervention Phase
Glaucoma
Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 47
Study Start Date: July 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00966576

Locations
Germany
Mainz, Germany, 55101
Sponsors and Collaborators
Alcon Research
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00966576     History of Changes
Other Study ID Numbers: SMA-08-22a
Study First Received: August 26, 2009
Last Updated: July 18, 2012
Health Authority: Germany: Ethics Commission

Keywords provided by Alcon Research:
Glaucoma
IOP
AZARGA

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 July 22, 2014