Clinical trial: Effect of Debridement-scaling on the Relief of Dry Eye Signs and Symptoms in Sjogren's Syndrome (NCT02203188)

Eligibility criteria:
Inclusion Criteria:

          -  Is at least 17 years of age and has full legal capacity to volunteer;

          -  Has read and signed an information consent letter;

          -  Is willing and able to follow instructions and maintain the appointment schedule;

          -  Is diagnosed with Sjogren's Syndrome;

          -  Meibomian gland score of ≤ 9 (out of 15);

          -  OSDI ≥ 23;

          -  Willing to maintain the use of OTC medications throughout the course of the study

          -  Have not worn contact lenses within the past 3 years

        Exclusion Criteria:

          -  Is participating in any concurrent clinical or research study;

          -  Has any known active* ocular disease and/or infection;

          -  Has a systemic condition, other than Sjogren's Syndrome and its associated conditions,
             that in the opinion of the investigator may affect a study outcome variable;

          -  Is using any systemic or topical medications, other than those indicated for Sjogren's
             Syndrome and its associated conditions, that in the opinion of the investigator may
             affect a study outcome variable;

          -  Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;

          -  Is pregnant, lactating or planning a pregnancy at the time of enrolment;

          -  Is aphakic;

          -  Has undergone refractive error surgery; * For the purposes of this study, active
             ocular disease is defined as infection or inflammation which requires therapeutic
             treatment. Lid abnormalities (blepharitis, meibomian gland dysfunction, papillae),
             corneal and conjunctival staining and dry eye are not considered active ocular
             disease. Neovascularization and corneal scars are the result of previous hypoxia,
             infection or inflammation and are therefore not active.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 17 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