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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

Clinical Trials [348 Associated Clinical Trials listed on BioPortfolio]

Prospective Evaluation of Open-Angle Glaucoma Subjects on One Topical Hypotensive Medication Treated With Two iStents

The purpose of this study is to evaluate the intraocular pressure (IOP) lowering effect of two iStent devices in eyes of subjects with primary open-angle glaucoma

A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension

Early Diagnosis, Pathogenesis and Progression of Open Angle Glaucoma

The Erlangen Glaucoma Registry is a clinical registry for cross sectional and longitudinal observation of patients with open angle glaucoma (OAG) or glaucoma suspect, founded in 1991. The ...

Phase II Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

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

Phase III Safety and Efficacy Study to Evaluate a Glaucoma Therapy in Open-Angle Glaucoma or Ocular Hypertension Patients

The purpose of this study is to determine the safety and IOP-lowering ability of a glaucoma therapy in patients with open-angle glaucoma or ocular hypertension

PubMed Articles [5127 Associated PubMed Articles listed on BioPortfolio]

Anterior Choroidal Thickness Increased in Primary Open-Angle Glaucoma and Primary Angle-Closure Disease Eyes Evidenced by Ultrasound Biomicroscopy and SS-OCT.

To compare the anterior and posterior choroid thickness (ACT and PCT, respectively) in primary open-angle glaucoma (POAG), primary angle-closure disease (PACD), and healthy control subjects.

Asymmetric Patterns of Visual Field Defect in Primary Open-Angle and Primary Angle-Closure Glaucoma.

To compare the hemifield asymmetry of visual field (VF) loss in primary open-angle glaucoma (POAG) and primary angle-closure glaucoma (PACG) across all severity levels.

Comparative evaluation of the aqueous humor proteome of primary angle closure and primary open angle glaucomas and age-related cataract eyes.

To analyze and compare the total proteome of aqueous humor (AH) from patients having primary angle closure glaucoma (PACG), primary open angle glaucoma (POAG) and age-related cataract.

Visual Disability among Juvenile Open Angle Glaucoma Patients.

Juvenile onset primary open angle glaucoma (JOAG) unlike adult onset primary open angle glaucoma presents with high IOP and diffuse visual field loss, which if left untreated leads to severe visual di...

Progression of Primary Open Angle Glaucoma in Diabetic and Non-diabetic Patients.

To compare the rates of visual field (VF) loss and retinal nerve fiber layer (RNFL) thinning in primary open angle glaucoma (POAG) patients with or without type 2 diabetes mellitus (DM).

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.

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

A quinoxaline derivative and ADRENERGIC ALHPA-2 RECEPTOR AGONIST that is used to manage INTRAOCULAR PRESSURE associated with OPEN-ANGLE GLAUCOMA and OCULAR HYPERTENSION.

Glaucoma in which the angle of the anterior chamber is open and the trabecular meshwork does not encroach on the base of the iris.

Congenital open-angle glaucoma that results from dysgenesis of the angle structures accompanied by increased intraocular pressure and enlargement of the eye. Treatment is both medical and surgical.

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