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

Launched by LANTIBIO · Jan 11, 2008

Keywords

ClinConnect Summary

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 irritati...

Gender

ALL

Eligibility 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®.