Clinical trial: Safety and Efficacy Assessment of Vismed® (Sodium Hyaluronate) for the Treatment of Dry Eye Syndrome (NCT00599716)

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®.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? Entailment