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

Use our guide to learn which trials are right for you!

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.
We found this trial at
1
site
6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
Alcon Call Center Alcon is helping people see the world better through advanced surgical, pharmaceutical...
1195
mi
from 91732
Fort Worth, TX
Click here to add this to my saved trials