Clinical trial: A Study to Assess the Safety and Efficacy of ECF843 vs Vehicle in Subjects With Dry Eye Disease (NCT04391894)

Eligibility criteria:
Inclusion Criteria:

          -  Written informed consent must be obtained before any assessment

          -  Adult male or female subjects 18 years of age or older

          -  At least 6 months history of dry eye disease in both eyes

          -  Must use, or feel the need to use, artificial tears/gels/lubricants on a regular basis

          -  Composite corneal fluorescein staining score ≥ 4 (modified National Eye Institute
             (NEI) scale) in at least one eye

          -  Schirmer score ≥ 1 and ≤ 10 mm after 5 minutes in at least one eye

          -  Patients with Sjögren's Syndrome

        Exclusion Criteria:

          -  Ocular infection in either eye within 30 days prior to Screening

          -  Use of artificial tears, gels, lubricants within 4 hours of the Screening Visit

          -  Use of contact lenses in either eye within 14 days of Screening

          -  Uncontrolled ocular rosacea

          -  Clinically significant conjunctivochalasis in either eye

          -  Corneal conditions

          -  Severe ocular conditions such as herpes, graft versus host disease, Stephen's Johnson
             Syndrome, sarcoidosis

          -  Currently active, or history of ocular allergies during the time of year the patient
             will be participating in the study

          -  Patients with current punctal plugs or punctal cauterization or occlusion

          -  Chronic medications (both over the counter and prescription) that have not been stable
             for at least 30 days prior to Screening.

          -  Use of Restasis®, Cequa®, or Xiidra® within 30 days prior to Screening

          -  Use of ocular, nasal, inhaled, or systemic corticosteroids within 30 days of Screening

          -  History of malignancy of any organs system

          -  Pregnant or nursing women
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? 1