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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00599716
Recruitment Status : Completed
First Posted : January 24, 2008
Last Update Posted : January 9, 2009
River Plate Biotechnology, Inc.
Rx Development Resources, LLC
Information provided by:

Brief 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®.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: sodium hyaluronate Drug: vehicle Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Double-Masked Study of Safety and Efficacy of Vismed® in Dry Eye Syndrome
Study Start Date : December 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
study drug
Drug: sodium hyaluronate
a sterile, unpreserved eye drop containing sodium hyaluronate in a proprietary formulation to be administered by ocular instillation
Other Names:
  • Vismed®
  • hyaluronic acid

Placebo Comparator: 2
vehicle control
Drug: vehicle
identical to proprietary formulation of active eye drop but without active ingredient, sodium hyaluronate

Primary Outcome Measures :
  1. staining of the cornea and conjunctiva [ Time Frame: Day 7 ]
  2. symptom frequency score [ Time Frame: Day 7 ]

Secondary Outcome Measures :
  1. staining of the cornea and conjunctiva [ Time Frame: Day 14 ]
  2. symptom frequency score [ Time Frame: Day 14 ]
  3. Quality of Life assessment [ Time Frame: Day 7 and Day 14 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 eyes diagnosed as dry eye syndrome, keratoconjunctivitis sicca (KCS), or due to Sjögren syndrome (immune exocrinopathy).
  • Subjects must agree to discontinue all artificial tears from Screening through the duration of the treatment period (Screening to Day 14).
  • Subjects who have taken Restasis® are eligible for inclusion if they have not used Restasis® during the 4 weeks prior to Screening.
  • Subjects must discontinue lens wear one week before Screening and agree not to wear contact lenses during the entire study.
  • Subjects must provide signed informed consent prior to participation in any study-related procedures.

Exclusion Criteria:

  • Pregnancy or lactation.
  • Females of childbearing potential who are not using systemic contraception, are not postmenopausal (≥ 1 year), or are not surgically sterilized.
  • Ocular surgery (of any type, including laser surgery) or ocular trauma within the 4 months prior to Screening.
  • Other diseases or characteristics judged by the investigator to be incompatible with the assessments needed in this study or with reliable instillation of the study medication.
  • 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®.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00599716

United States, Florida
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States, 33426
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
East Florida Eye Institutue
Stuart, Florida, United States, 34994
Abrams Eye Center
Stuart, Florida, United States, 44115
International Eye Center
Tampa, Florida, United States, 33603
United States, Indiana
American Eye Institute
New Albany, Indiana, United States, 47150
United States, Missouri
Comprehensive Eye Care
Washington, Missouri, United States, 63090
United States, North Carolina
Charlotte Eye, Ear, Nose and Throat
Charlotte, North Carolina, United States, 28210
United States, Pennsylvania
Ophthalmic Research & Clinical Studies
Moon Twp, Pennsylvania, United States, 15108
United States, Tennessee
Chattanooga Eye Institute
Chattanooga, Tennessee, United States, 37411
Sponsors and Collaborators
River Plate Biotechnology, Inc.
Rx Development Resources, LLC
Study Chair: Roger Vogel, MD Rx Development Resources, LLC
Study Director: Terry Laliberte, BS River Plate Biotechnology, Inc.
Principal Investigator: Charles (Andy) Kirby, MD Chattanooga Eye Institute, Chattanooga, TN
Principal Investigator: Mark Abrams, MD Abrams Eye Center, Cleveland, OH

Responsible Party: Terry W. Laliberte/Director of Development, River Plate Biotechnology, Inc./Lantibio, Inc. Identifier: NCT00599716     History of Changes
Other Study ID Numbers: RP-001
First Posted: January 24, 2008    Key Record Dates
Last Update Posted: January 9, 2009
Last Verified: January 2009

Keywords provided by Lantibio:
dry eye syndrome
dry eye disease
dry eye
sodium hyaluronate
hyaluronic acid

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Protective Agents