Clinical trial: Levocarnitine for Dry Eye in Sjogren's Syndrome (NCT03953703)

Eligibility criteria:
Inclusion Criteria:

          1. Clinician diagnosis of primary or secondary SjS.

          2. Positive anti-SSA

          3. Diagnosis of keratoconjunctivitis sicca defined by OSDI ≥ 25 and Schirmer's test ≤
             5mm/5min in at least 1 eye.

          4. Stable medications for past 4 weeks

        Exclusion Criteria:

          1. Age <18 or >75 at screening visit

          2. Pregnant or nursing, or women of childbearing potential unwilling to use a medically
             acceptable form of birth control

          3. Unwilling or unable to stop the use of any artificial tear formulations containing
             L-carnitine.

          4. Taking any form of levocarnitine supplementation or nutritional supplements containing
             L-carnitine within 2 months prior to enrollment

          5. Unwilling to discontinue immunomodulatory (e.g. Restasis, Xiidra), anti-inflammatory
             (e.g. steroid containing) eye drops, or serum tears for 1 month prior and throughout
             the duration of the study

          6. Unwilling to discontinue wearing contact lenses for 1 month prior and throughout the
             duration of the study

          7. Planned occlusion of the lacrimal puncta with either punctal plugs or cauterization
             during the study

          8. Laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), or
             radial keratectomy

          9. Ocular surgery/trauma in the last 6 months or planned during the study

         10. History of ocular infection, including severe blepharitis, in the last 3 months

         11. Active ocular allergy that, in the opinion of the investigator, would compromise
             interpretation of the data

         12. Elevated AST, ALT, alkaline phosphatase or bilirubin above the upper limit of normal
             at screening

         13. Renal insufficiency defined by a creatinine clearance of less than 30 ml/min (CKD-EPI
             or MDRD formula)

         14. Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the
             investigational drug, whichever is longer) of the screening visit

         15. Laboratory parameters at the pre-treatment visit showing any of the following abnormal
             results: neutrophil count < 1,500/mm3; platelet count < 100,000/mm3; hemoglobin < 9
             g/dL

         16. Contraindications to the class of drugs under study, e.g. known hypersensitivity or
             allergy to class of drugs or the investigational product

         17. The patient has a known defect in oxidative phosphorylation (such as a confirmed
             mitochondrial myopathy)

         18. Any medical or psychiatric condition, which in the opinion of the investigator, places
             the subject at unacceptable risk or which might compromise the validity of the
             collected data

         19. Allogeneic BMT or chemotherapy in the past 3 months
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 75 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