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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma; Ocular Hypertension; Open-angle Glaucoma

Intervention: Brinzolamide 1% / timolol 0.5% maleate fixed combination (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Danyel C. Carr, MS, CCRA, Study Director, Affiliation: Alcon Research

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).

Clinical Details

Official title: Assessing the Efficacy and Tolerability of AZARGA (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Canada

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

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

Secondary outcome: Percentage of Subjects Who Reach Target IOP (≤ 18 mmHg)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Known history of hypersensitivity to any component of the preparations used in this

study.

- Presence of primary or secondary glaucoma not listed in inclusion criterion #2.

- 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.

- Other protocol-defined exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: September 2011
Last updated: May 30, 2014

Page last updated: August 23, 2015

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