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AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01484951
First received: December 1, 2011
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  Purpose

The purpose of this study was to assess the safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.


Condition Intervention Phase
Glaucoma
 Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessing the Safety and Efficacy of Switching to AZARGA® (Brinzolamide/Timolol Fixed Combination) as Replacement Therapy in Patients With Uncontrolled Intraocular Pressure in Taiwan

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
    As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.


Secondary Outcome Measures:
  • Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.


Enrollment: 74
Study Start Date: May 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AZARGA
Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
 Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops
Other Name: AZARGA®

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
  • Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
  • Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
  • Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
  • Must have 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 medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
  • Any abnormality preventing reliable applanation tonometry in either eye.
  • Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
  • Pregnant or lactating.
  • Participation in any other investigational study within 30 days of screening visit.
  • Other protocol-defined exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01484951

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: NCT01484951     History of Changes
Other Study ID Numbers: SMA-10-11
Study First Received: December 1, 2011
Results First Received: March 12, 2013
Last Updated: April 25, 2013
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Alcon Research:
Open-angle glaucoma
Ocular hypertension
Pigment dispersion glaucoma

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases
Timolol
Tetrahydrozoline
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
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 21, 2013