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

PHASE3CompletedINTERVENTIONAL
Enrollment

300

Participants

Timeline

Start Date

December 31, 2006

Primary Completion Date

April 30, 2008

Study Completion Date

May 31, 2008

Conditions
Dry Eye Disease
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

Trial Locations (10)

15108

Ophthalmic Research & Clinical Studies, Moon Twp

28210

Charlotte Eye, Ear, Nose and Throat, Charlotte

33176

Center for Excellence in Eye Care, Miami

33426

Florida Eye Microsurgical Institute, Boynton Beach

33603

International Eye Center, Tampa

34994

East Florida Eye Institutue, Stuart

37411

Chattanooga Eye Institute, Chattanooga

44115

Abrams Eye Center, Stuart

47150

American Eye Institute, New Albany

63090

Comprehensive Eye Care, Washington

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

River Plate Biotechnology, Inc.

INDUSTRY

collaborator

Rx Development Resources, LLC

UNKNOWN

lead

Lantibio

INDUSTRY