AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01484951
• Other study ID #: SMA-10-11
• Status: Completed
• Phase: Phase 4
• First received: December 1, 2011
• Last updated: April 25, 2013
• Start date: May 2011
• Est. completion date: March 2012

Study information

• Verified date: April 2013
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)	As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.	Baseline, Week 8	No
Secondary	Percentage of Patients With Target IOP (=18 mmHg), Regardless of Prior Therapy	As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.	Week 8	No