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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lantibio
• Collaborators: River Plate Biotechnology, Inc.; Rx Development Resources, LLC
• Treatments: Hyaluronic Acid

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®.