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Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Glaucoma

Intervention: Brinzolamide/timolol maleate fixed combination (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
Doug Hubatsch, Study Director, Affiliation: Alcon Research

Summary

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA from prior COMBIGAN pharmacotherapy in participants with open-angle glaucoma or ocular hypertension.

Clinical Details

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

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

Primary outcome: Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8

Secondary outcome: Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8

Eligibility

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

Criteria:

Inclusion Criteria:

- Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or

pigment dispersion glaucoma in at least one eye (study eye).

- On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening

Visit.

- IOP considered safe in both eyes in order to assure clinical stability of vision and

optic nerve throughout the study period.

- Best corrected visual acuity of 6/60 (20/200 Snellen; 1. 0 LogMAR) or better in each

eye.

- IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while

on brimonidine/timolol fixed combination therapy.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Presence of other primary or secondary glaucoma.

- History of ocular herpes simplex.

- Any 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 three

months prior to Screening Visit.

- Risk of visual field or visual acuity worsening as a consequence of participation in

the study, in the opinion of the investigator.

- Progressive retinal or optic nerve disease from any cause.

- Use of systemic medications known to affect IOP which have not been on a stable

course for 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.

- Pregnant or lactating.

- Other protocol-defined exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: December 2011
Last updated: July 17, 2015

Page last updated: August 20, 2015

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