Open Angle Glaucoma
Conditions
Keywords
Open angle glaucoma, OAG, Elazop, Azarga, Brinzolamide/Timolol combination
Brief summary
The purpose of this study is to assess the safety and efficacy of switching to ELAZOP from prior pharmacotherapy in patients with open-angled glaucoma.
Interventions
DRUGElazop (Azarga)
Administer one drop of ELAZOP in treated eye(s) twice a day for up to 12 weeks
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older. * Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes. * Must be on a stable regimen of Intraocular Pressure (IOP) lowering medication (i.e., either a single therapeutic agent or two separate ocular hypotensive agents) for at least one month prior to the Screening Visit. * Must have IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period. * Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the preparations to be used in the study that is deemed clinically significant in the opinion of the Principal Investigator. * Intraocular conventional surgery or laser surgery in either eye less than three months prior to the Screening visit. * History of ocular herpes simplex. * Pregnant or lactating. * Participation in any other investigational study within 30 days of Screening visit. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Intraocular Pressure (IOP) change from baseline at final visit. | 12 weeks after treatment |
Countries
South Korea
Outcome results
None listed