Clinical trial: TrueTear in Sjogren's Disease Patients (NCT03719885)

Eligibility criteria:
Inclusion Criteria:

          -  Subjects with Sjögren's syndrome based on American-European Consensus Group (AECG)
             American College of Rheumatology (ACR), or American College of Rheumatology/European
             League Against Rheumatism (ACR/EULAR) criteria

          -  Baseline Schirmer score (with topical anesthesia) of ≤10 mm/5 min and retest value
             (during nasal stimulation with cotton swab) of at least 4 mm/5min higher than baseline
             value

          -  Baseline Ocular Surface Disease Index® (OSDI) total score ≥13

          -  Age greater than or equal to 22 years old

          -  Able to complete questionnaires independently

          -  Willing to sign the informed consent and deemed capable of complying with the
             requirements of the study protocol

        Exclusion Criteria:

          -  Use of any topical ophthalmic medication, including artificial tears, within 4 hours
             of either visit

          -  Chronic or recurrent epistaxis, coagulation disorders or other conditions that, in the
             opinion of the investigator, may lead to clinically significant increased bleeding

          -  Use of systemic anticoagulants

          -  Nasal or sinus surgery including nasal cautery or significant trauma

          -  Severely deviated septum

          -  Cardiac demand pacemaker, implanted defibrillator or other implanted electronic device

          -  Have an active implanted metallic or active implanted electronic device in the head, a
             cardiac demand pacemaker, or an implanted defibrillator

          -  Known hypersensitivity to any of the procedural agents or materials in the study
             device that contact the nasal mucosa

          -  Corneal transplant in either or both eyes

          -  Participation in any clinical trial within 30 days of the Screening Visit

          -  A woman who is pregnant, planning a pregnancy, or nursing at the Screening Visit
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 22 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