Clinical trial: Differential Diagnosis of Sjögren's Versus Non-Sjögren's Dry Eye (NCT04493658)

Eligibility criteria:
Inclusion Criteria:

          -  Capacity to give informed consent

          -  Self-reported literacy

          -  Best corrected visual acuity at distance 20/40 in each eye

          -  Signed Institutional Review Board (IRB) approved consent agreeing to terms of the
             study

               -  Additional inclusion criteria for the dry eye group (both SS- and non-SS) will
                  include a previous diagnosis of dry eye made by an eye care specialist.

               -  Differentiation of SS-related versus non-SS dry eye will be made according to the
                  2016 revised SS classification criteria.

        The classification criteria are based on the weighted sum of the below 5 items:

        • SS laboratory findings

          -  Anti-Sjogren's Antibody A (SSA) antibody positivity

          -  Focal lymphocytic sialadenitis with a focus score ≥ 1 foci/mm2

        each scoring=3

        • SS clinical findings

          -  Abnormal ocular staining score ≥ 5 (or van Bijsterveld score ≥ 4) in one eye

          -  Schirmer test ≤ 5 mm/5 min (without anesthesia) in one eye

          -  Unstimulated salivary flow rate ≤ 0.1 mL/min

        each scoring=1

        Individuals who have a total score ≥ 4 for the items above, meet the criteria for primary
        SS. In other words, for final classification, an individual should have at least one
        laboratory and one clinical finding.

        Additional inclusion criteria for control subjects will include no previous history of dry
        eye diagnosis, and no known history of autoimmune disease, verified using a review of
        systems and past medical history form.

        Exclusion Criteria:

          -  Age less than 18 years

          -  Known diagnoses of: Hepatitis C infection, HIV infection, Sarcoidosis, Amyloidosis,
             Graft Versus Host Disease (GVHD), Cicatrizing conjunctivitis (ie. from trachoma,
             Stevens-Johnsons Syndrome (SJS), pemphigoid, drug induced pseudo-pemphigoid, or
             chemical burns, other severe ocular surface diseases such as atopic
             keratoconjunctivitis

          -  Physical or mental issues, illiteracy, language problems which might possibly
             interfere with reading ability or other condition that would preclude successful
             participation in this study

          -  Contact lens wear within 10 days of enrollment

          -  Any intraocular surgery (including cataract surgery) within the last 3 months

          -  Any minor ocular surgery including tear duct cauterization or plugs, within the last
             30 days

          -  Any history of corneal surgery or cosmetic lid surgery in the past 12 months

          -  Best corrected vision worse than 20/40

          -  Pregnant or nursing

          -  Artificial tear use within 24 hours of study visit

          -  History of taking or current use of topical prescription eye drops (including,
             cyclosporine and steroids as well as any glaucoma eye drops).

               -  Patients who are willing to discontinue their treatment for at least a period of
                  30 days can be placed on a "wash-out period" as per the discretion of the
                  investigator and patient safety, and be eligible at the end of this period, given
                  all other criteria have been met. Otherwise, patients on these medications will
                  be excluded.

               -  Any person treated with glaucoma drops in the past (more than 30 days ago) or who
                  had glaucoma surgery (more than 12 months ago) can be included.

                    -  Additional exclusion criteria for control subjects will include previous
                       history of dry eye diagnosis, or history of any known autoimmune,
                       inflammatory or rheumatologic disease including but not limited to Sjögren's
                       syndrome, rheumatoid arthritis, Lupus, mixed connective tissue disease,
                       scleroderma. Also the above exclusion criteria apply to control subjects.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
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? Entailment