Status:
TERMINATED
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 Brazil
Lead Sponsor:
Alcon Research
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion
- 18 years of age or older.
- Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
- Be on a stable intraocular pressure (IOP) lowering regimen within 30 days of the Screening Visit.
- IOP considered safe in both eyes in such a way that should 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
- Presence of other primary or secondary glaucoma not listed in inclusion criteria #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 three 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.
- Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the 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.
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT01514734
Start Date
March 1 2012
End Date
August 1 2012
Last Update
October 21 2013
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
São Paulo, Brazil, 11045-140