Levocarnitine for Dry Eye in Sjogren's Syndrome

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
• •20. The patient has a history of seizure activity.
• •21. History of a cornea transplant
• •22. Herpes simplex or herpes zoster infection in the eye
• •23. Eyelid tattooing (permanent eyelining)
• •24. Current diagnoses of any of the following conditions: acute allergic conjunctivitis, inflammation (e.g, retinitis macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis)
• •25. On glaucoma eye-drops or eye-drops for lowering eye pressure
• •26. Known diagnoses of: Hepatitis C infection, HIV infection, Sarcoidosis, Amyloidosis, Graft versus host disease, Cicatrizing conjunctivitis (e.g. from trachoma, Stevens-Johnson syndrome, pemphigoid, drug induced pseudo-pemphigoid, or chemical ocular burns), Pre-existing lymphoma in patients with no prior diagnosis of SS, Past head and neck radiation treatment
• •27. Condition that may compromise ocular surface integrity: trachoma, Stevens-Johnson syndrome, pemphigoid, graft versus host disease, prior chemical burn, recurrent corneal erosions, persistent corneal epithelial defects, prior ocular trauma
• •28. Issues with closing eyelids completely or having eyelashes rub on surface of eye
• •29. Unwilling to discontinue oral supplements for dry eye like fish oil for 1 month prior and throughout study duration
• •30. Unwilling to discontinue use of Tyrvaya (varenicline) nasal spray for 1 month prior and throughout study duration