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ELAZOP Switching Study in Korea

2014-08-27 03:16:26 | BioPortfolio

Summary

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.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Open Angle Glaucoma

Intervention

Elazop (Azarga)

Location

Seoul National University Bundang Hospital
Sungnam
Gyounggi
Korea, Republic of
463-707

Status

Not yet recruiting

Source

Alcon Research

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:16:26-0400

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To determine the safety and IOP-lowering ability of a test compound in patients with open-angle glaucoma or ocular hypertension.

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PubMed Articles [4831 Associated PubMed Articles listed on BioPortfolio]

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Medical and Biotech [MESH] Definitions

A cloprostenol derivative that is used as an ANTIHYPERTENSIVE AGENT in the treatment of OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.

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