AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure

NCT01484951 | Completed Phase 4 Results

• 1 other identifier: SMA-10-11
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Glaucoma

Keywords

Open-angle glaucoma; Ocular hypertension; Pigment dispersion glaucoma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy

  Week 8

Study Arms (1)

AZARGA

EXPERIMENTAL

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

Interventions

Brinzolamide 1% and timolol 0.5% fixed combination eye drops DRUG

Also known as: AZARGA®

AZARGA

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Timolol; Azarga

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Abayomi Ogundele, Pharm.D
• Organization: Alcon Global Medical Affairs

1-888-451-3937

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2011
• First Posted: December 5, 2011
• Study Start: May 1, 2011
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 1, 2013
• Results First Posted: April 26, 2013

Record last verified: 2013-04

Locations

US (1)