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Purpose: Phase IV switching study to Elazop to evaluate efficacy and safety in patients with open angle glaucoma
This is a multi-center, open-labeled, exploratory, interventional, prospective study. The study will not be conducted concurrently at all clinical sites. The 12 weeks study consists of 4 different study visits to the clinical site (Screening, Day 1, Week 4 and Week 12). During Visit 1 (Screening Visit), patients will be assessed for their eligibility to participate in the study; an intraocular pressure (IOP) measurement will be taken to determine if the patient's IOP is within the required range for this study (between 16 to 35 mmHg, both inclusive). The patients who meet the eligible criteria will be required to stop taking their previous ocular hypertensive medications for 4 weeks washout period following the screening visit. At the Day 1 Visit (baseline visit), eligibility of the patients will be reconfirmed (i.e., IOP range must be between 16 to 35 mmHg, both inclusive). At Day 1 Visit, eligible patients will the receive study medication with proper dosing instructions (to be administered twice a day) for up to 12 weeks. Patients will be required to return to the clinical site at Visit 3 (Week 4) for IOP measurements and safety assessments. At the Visit 4 (Week 12; exit visit), the patient's IOP will be measured and then patients will be exited from the study after all exit procedures have been completed.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Open Angle Glaucoma
Seoul National University Bundang Hospital
Korea, Republic of
Not yet recruiting
Published on BioPortfolio: 2014-08-27T03:16:26-0400
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Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...