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

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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


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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