AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

Alcon

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01484951

SMA-10-11

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

74 participants in 1 patient group

AZARGA

Experimental group

Description:

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.

Treatment:

Drug: Brinzolamide 1% and timolol 0.5% fixed combination eye drops