Clinical trial: Efficacy of T1675 Versus Placebo in Patients With Bilateral Treated Moderate Dry Eye Syndrome (NCT00357201)

Eligibility criteria:
Inclusion Criteria:

          -  Signed and dated informed consent.

          -  Male or female aged from 18 to 90 years old.

          -  Known treated bilateral dry eye.

          -  Dry eye syndrome confirmed by ocular examination with a fluorescein and/or lissamine
             green staining, BUT and Schirmer, performed within the last 12 months before Inclusion
             Visit, for both eyes.

          -  Bilateral symptomatology suggestive of dry eye defined by: at least one of the
             following ocular symptoms suggestive of dry eye (burning, stinging, dryness feeling,
             sandy and/or gritty sensation, light sensitivity, reflex tearing, ocular fatigue) and
             Questioning on patient's feeling (score >=3).

          -  Fulfilling the following criteria of dry eye syndrome in both eyes defined by:
             Keratoconjunctivitis defined by a lissamine green score ≥ 4 (Van Bijsterveld score)
             and Schirmer test <= 10 mm in 5 min or BUT < 10 s

        Exclusion Criteria:

          -  severe dry eye symptom

          -  eyelid dysfunction

          -  severe progressive rosacea

          -  any relevant ocular anomaly interfering with ocular surface

          -  best corrected far visual acuity <= 1/10

          -  history of ocular allergy

          -  traumatism, infection, inflammation within last 3 months

          -  ocular surgery and laser within the last 3 months

          -  lasik, laser, PKR within the last 12 months

          -  contact lenses

          -  any concomitant nutritive supplementation, vitamins

          -  any topical concomitant treatment
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.
Subject must be at most 90 Years

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? 0