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

Sponsors and Collaborators:	Lantibio River Plate Biotechnology, Inc. Rx Development Resources, LLC
Information provided by:	Lantibio
ClinicalTrials.gov Identifier:	NCT00599716

Purpose

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	Intervention	Phase
Dry Eye Disease	Drug: sodium hyaluronate Drug: vehicle	Phase III

MedlinePlus related topics: Dietary Sodium Eye Diseases

Drug Information available for: Tetrahydrozoline Tetrahydrozoline hydrochloride Hyaluronate Sodium Hyaluronic acid

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 3, Multicenter, Randomized, Double-Masked Study of Safety and Efficacy of Vismed® in Dry Eye Syndrome

Further study details as provided by Lantibio:

Primary Outcome Measures:

staining of the cornea and conjunctiva [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
symptom frequency score [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

staining of the cornea and conjunctiva [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
symptom frequency score [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
Quality of Life assessment [ Time Frame: Day 7 and Day 14 ] [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	December 2006
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental study drug	Drug: sodium hyaluronate a sterile, unpreserved eye drop containing sodium hyaluronate in a proprietary formulation to be administered by ocular instillation
2: Placebo Comparator vehicle control	Drug: vehicle identical to proprietary formulation of active eye drop but without active ingredient, sodium hyaluronate

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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®.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599716

Locations

United States, Florida
Abrams Eye Center
Stuart, Florida, United States, 44115
Center for Excellence in Eye Care
Miami, Florida, United States, 33176
International Eye Center
Tampa, Florida, United States, 33603
Florida Eye Microsurgical Institute
Boynton Beach, Florida, United States, 33426
East Florida Eye Institutue
Stuart, Florida, United States, 34994
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

Lantibio

River Plate Biotechnology, Inc.

Rx Development Resources, LLC

Investigators

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

More Information

click here for more information about this study: A Phase 3, Multicenter, Randomized, Double-Masked Study of Safety and Efficacy of Vismed® in Dry Eye Syndrome This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Responsible Party:	River Plate Biotechnology, Inc./Lantibio, Inc. ( Terry W. Laliberte/Director of Development )
Study ID Numbers:	RP-001
Study First Received:	January 11, 2008
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00599716
Health Authority:	United States: Food and Drug Administration

Keywords provided by Lantibio:

dry eye syndrome
dry eye disease
Vismed

dry eye
sodium hyaluronate
hyaluronic acid

Study placed in the following topic categories:

Hyaluronic Acid
Eye Diseases
Lacrimal Apparatus Diseases
Dry Eye Syndromes
Tetrahydrozoline

Additional relevant MeSH terms:

Pathologic Processes
Disease
Immunologic Factors
Syndrome

Physiological Effects of Drugs
Adjuvants, Immunologic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009