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

Last updated: January 8, 2009
Sponsor: Lantibio
Overall Status: Completed

Phase

3

Condition

Eyelid Inflammation

Sjogren's Syndrome

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT00599716
RP-001
  • Ages > 18
  • All Genders

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®.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female adults aged 18 years and over.

  • Subjects should have at least a 3-month documented history of dry eye in both eyesdiagnosed as dry eye syndrome, keratoconjunctivitis sicca (KCS), or due to Sjögrensyndrome (immune exocrinopathy).

  • Subjects must agree to discontinue all artificial tears from Screening through theduration of the treatment period (Screening to Day 14).

  • Subjects who have taken Restasis® are eligible for inclusion if they have not usedRestasis® during the 4 weeks prior to Screening.

  • Subjects must discontinue lens wear one week before Screening and agree not to wearcontact lenses during the entire study.

  • Subjects must provide signed informed consent prior to participation in anystudy-related procedures.

Exclusion

Exclusion Criteria:

  • Pregnancy or lactation.

  • Females of childbearing potential who are not using systemic contraception, are notpostmenopausal (≥ 1 year), or are not surgically sterilized.

  • Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4months prior to Screening.

  • Other diseases or characteristics judged by the investigator to be incompatible withthe assessments needed in this study or with reliable instillation of the studymedication.

  • Any active inflammation of the eye not due to KCS (eg, iritis, scleritis, etc.).

  • Participation in any other clinical trial within 30 days prior to Screening.

  • Prior participation in a previous clinical trial of Vismed®.

Study Design

Total Participants: 300
Study Start date:
December 01, 2006
Estimated Completion Date:
May 31, 2008

Study Description

VISMED® is currently marketed in Europe under the CE mark as a viscoelastic lubricant eye drop. The proprietary formulation contains a highly purified specific fraction of sodium hyaluronate. Sodium hyaluronate is a natural polymer which is also present in the structures of the human eye. Its main physical characteristic is viscoelasticity. This means that VISMED® has a high viscosity between blinks and a low viscosity during blinking ensuring efficient coating of the surface of the eye. It is believed that this protective coating of the surface of the eye helps prevent dryness and irritation. Sodium hyaluronate also possesses mucoadhesive properties and the ability to entrap water, thus resembling tear mucus glycoprotein. This, together with the coating properties of sodium hyaluronate, results in an increased pre-corneal residence time and tear film break-up time (BUT) and therefore longer lubrication of the eye surface. VISMED® is completely free of preservatives. As a result, it is non-irritating to ocular tissues and can be used frequently and for extended periods without harming the surface of the eye (e.g. without causing superficial punctate keratitis). Some preservatives are known to cause toxic or allergic reactions, the symptoms of which include stinging, burning and redness of the eyes. To further maximize patient comfort, the pH of VISMED® is adjusted to 7.3, similar to that of the natural tear film.

Hydrogels of sodium hyaluronate have been used for many years in ophthalmic surgery in Europe and the U.S. to maintain the shape of the eye, to cover surgical instruments and to protect the corneal endothelium from damage. They have unique physical properties that make them ideal for use in the treatment of Dry Eye Syndrome. Therefore, VISMED® represents a new class of compound in development for the treatment of dry eye in the US, offering lubricant properties which can alleviate the discomfort and reverse ocular damage caused by dry eye syndrome.

This study is being conducted to supplement the body of knowledge gained from studies conducted in Europe and regulatory approvals granted there to formalize the safety and efficacy of Vismed® to meet FDA requirements for a New Drug Application to market the product in the US.

Connect with a study center

  • Florida Eye Microsurgical Institute

    Boynton Beach, Florida 33426
    United States

    Site Not Available

  • Center for Excellence in Eye Care

    Miami, Florida 33176
    United States

    Site Not Available

  • Abrams Eye Center

    Stuart, Florida 44115
    United States

    Site Not Available

  • East Florida Eye Institutue

    Stuart, Florida 34994
    United States

    Site Not Available

  • International Eye Center

    Tampa, Florida 33603
    United States

    Site Not Available

  • American Eye Institute

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Comprehensive Eye Care

    Washington, Missouri 63090
    United States

    Site Not Available

  • Charlotte Eye, Ear, Nose and Throat

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Ophthalmic Research & Clinical Studies

    Moon Twp, Pennsylvania 15108
    United States

    Site Not Available

  • Chattanooga Eye Institute

    Chattanooga, Tennessee 37411
    United States

    Site Not Available

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