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
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