Status:
COMPLETED
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
20+ years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01484951
Start Date
May 1 2011
End Date
March 1 2012
Last Update
May 1 2013
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134