Efficacy and Tolerability of AZARGA® as Replacement Therapy in Patients on COMBIGAN® Therapy in Canada

NCT01415401 | Completed Phase 4 Results

• 1 other identifier: RDG-11-199
• Study Type: interventional
• Target: 57
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior brimonidine 0.2%/timolol 0.5% fixed combination (COMBIGAN®) therapy in patients with open-angle glaucoma or ocular hypertension and uncontrolled intraocular pressure (IOP).

Conditions

Glaucoma; Ocular Hypertension; Open-angle Glaucoma

Keywords

Glaucoma; Ocular hypertension; Intraocular pressure (IOP); Open angle glaucoma; Pigment dispersion glaucoma; Pigmentary

Outcome Measures

Primary Outcomes (1)

• Change in IOP at the Final Visit From Prior Brimonidine 0.2%/Timolol 0.5% Fixed Combination (COMBIGAN®) Therapy (i.e. From Baseline)

  IOP (fluid pressure inside the eye) was assessed by Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.

  Baseline, Week 8

Secondary Outcomes (1)

• Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)

  Week 8

Study Arms (1)

AZARGA

EXPERIMENTAL

Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)

Drug: Brinzolamide 1% / timolol 0.5% maleate fixed combination

Interventions

Brinzolamide 1% / timolol 0.5% maleate fixed combination DRUG

Also known as: AZARGA®

AZARGA

Eligibility Criteria

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

You may qualify if:

• Willing to sign an Informed Consent form.
• Clinical diagnosis of ocular hypertension, exfoliative open-angle or pigment dispersion glaucoma in at least one eye (study eye).
• Be on a stable IOP lowering regimen within 30 days of Screening Visit.
• IOP considered to be safe, in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
• Willing to discontinue the use of COMBIGAN® prior to receiving the study drug at Visit 1.
• IOP of between 19 and 35 mmHg in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
• Best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 logMAR) or better in each eye.
• Willing to follow instructions and able to attend required study visits.

You may not qualify if:

• Known history of hypersensitivity to any component of the preparations used in this study.
• History of ocular herpes simplex.
• Abnormality preventing reliable applanation tonometry.
• Corneal dystrophies.
• Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
• Intraocular conventional surgery or laser surgery in study eye(s) less than 3 months prior to the Screening Visit.
• Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
• Progressive retinal or optic nerve disease from any cause.
• Women of childbearing potential not using reliable means of birth control for at least 1 month prior to the Screening/Baseline Visit.
• Pregnant or lactating.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma; Ocular Hypertension; Glaucoma, Open-Angle

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: Doug Hubatsch, Global Brand Leader
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Danyel C. Carr, MS, CCRA

  Alcon Research

  STUDY DIRECTOR

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: August 10, 2011
• First Posted: August 12, 2011
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 1, 2014
• Results First Posted: July 1, 2014

Record last verified: 2014-05