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Safety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye Syndrome

NCT00599716 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2009-01-09

No results posted yet for this study

Summary

The study is designed to assess the safety and efficacy of Vismed®, a special eye drop containing sodium hyaluronate, in the treatment of dry eye syndrome. Vismed® is being compared to another eye drop, identical in composition except that it does not contain the active ingredient, sodium hyaluronate. This eye drop is designed as the "vehicle." Some subjects are to receive Vismed® treatment, while others are to receive the vehicle; the assignment of subjects to receive either Vismed or vehicle is to be random. The two-week treatment phase is followed by a one week follow-up period to evaluate safety of Vismed®.

Conditions

Interventions

DRUG

sodium hyaluronate

a sterile, unpreserved eye drop containing sodium hyaluronate in a proprietary formulation to be administered by ocular instillation

DRUG

vehicle

identical to proprietary formulation of active eye drop but without active ingredient, sodium hyaluronate

Sponsors & Collaborators

  • River Plate Biotechnology, Inc.

    collaborator INDUSTRY

  • Rx Development Resources, LLC

    collaborator UNKNOWN

  • Lantibio

    lead INDUSTRY

Principal Investigators

  • Roger Vogel, MD · Rx Development Resources, LLC

  • Terry Laliberte, BS · River Plate Biotechnology, Inc.

  • Charles (Andy) Kirby, MD · Chattanooga Eye Institute, Chattanooga, TN

  • Mark Abrams, MD · Abrams Eye Center, Cleveland, OH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2008-04-30
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00599716 on ClinicalTrials.gov