Dry Eye Disease Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-Masked Study of Safety and Efficacy of Vismed® in Dry Eye Syndrome
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®.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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