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AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

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ClinicalTrials.gov Identifier: NCT01484951
Recruitment Status : Completed
First Posted : December 5, 2011
Results First Posted : April 26, 2013
Last Update Posted : May 1, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Glaucoma Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : May 2011
Primary Completion Date : March 2012
Study Completion Date : March 2012

Arms and Interventions

Arm Intervention/treatment
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®

Outcome Measures

Primary Outcome Measures :
  1. Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only) [ Time Frame: Baseline, Week 8 ]
    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 :
  1. Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy [ Time Frame: Week 8 ]
    As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 ClinicalTrials.gov identifier (NCT number): NCT01484951

United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
More Information

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01484951     History of Changes
Other Study ID Numbers: SMA-10-11
First Posted: December 5, 2011    Key Record Dates
Results First Posted: April 26, 2013
Last Update Posted: May 1, 2013
Last Verified: April 2013

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

Additional relevant MeSH terms:
Ocular Hypertension
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nasal Decongestants
Vasoconstrictor Agents
Respiratory System Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors