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 Latin America
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/30/2013 |
Start Date: | January 2012 |
End Date: | March 2013 |
Contact: | Alcon Call Center |
Phone: | 1-888-451-3937 |
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
The objective of this study is to assess the efficacy and tolerability of changing to
AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular
hypertension.
Inclusion Criteria:
- 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 IOP (intra-ocular pressure) 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 Criteria:
- 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 studyl.
- Pregnant or lactating.
- Other protocol-defined exclusion criteria may apply.
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