Clinical trial: LAMELLEYE for the Treatment of Dry Eye Symptoms in pSS Patients (NCT03140111)

Eligibility criteria:
Inclusion Criteria:

        To be eligible for inclusion, each Participant must meet each of the following:

          1. Male or female aged ≥ 18 years and ≤ 79 years at date of consent

          2. Primary Sjögren's Syndrome diagnosed by a rheumatologist

          3. Patient has symptoms of dry eye, and has failed to achieve symptom relief on adequate
             trial of standard topical therapy

          4. Willing and able to attend Glasgow Caledonian University Vision Sciences Eye Clinic
             for therapy assessment; and to comply with all procedures and follow-up visits

          5. Participant must have personally given written informed consent to allow anonymised
             data to be used in publications and presentations.

        Exclusion Criteria:

        Participants are excluded from the study if any of the following criteria are met:

          1. Females who are pregnant, planning pregnancy or breastfeeding

          2. Active ocular infection or current corneal ulceration

          3. Ocular surgery within 6 months of study start date

          4. Current contact lens wear

          5. Any prior and/or current topical ophthalmic treatments that in the opinion of the CI
             or PI may interfere with the study outcomes

          6. Started or changed the dose of chronic systemic medication known to affect tear
             production including, but not limited to antihistamines, anticholinergics,
             antidepressants, diuretics, corticosteroids or immunomodulators within 30 days prior
             to enrolment

          7. Participants with known allergies to ingredients in any of the study treatments, or
             fluorescein

          8. Participants who are judged inappropriate for inclusion in the study by the CI or PI.
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 79 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? Entailment