Levocarnitine for Dry Eye in Sjogren's Syndrome

Prior treatment

• Taking any form of levocarnitine supplementation or nutritional supplements containing L-carnitine within 2 months prior to enrollment
• Unwilling to discontinue wearing contact lenses for 1 month prior and throughout the duration of the study
• Ocular surgery/trauma in the last 6 months or planned during the study
• Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the screening visit
• Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product
• Allogeneic BMT or chemotherapy in the past 3 months
• 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
• 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
• Unwilling to discontinue oral supplements for dry eye like fish oil for 1 month prior and throughout study duration
• Unwilling to discontinue use of Tyrvaya (varenicline) nasal spray for 1 month prior and throughout study duration

Other illness

• History of ocular infection, including severe blepharitis, in the last 3 months
• Active ocular allergy that, in the opinion of the investigator, would compromise interpretation of the data
• 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
• The patient has a history of seizure activity.
• History of a cornea transplant
• Herpes simplex or herpes zoster infection in the eye
• Current diagnoses of any of the following conditions: acute allergic conjunctivitis, inflammation (e.g, retinitis macular inflammation, choroiditis, uveitis, scleritis, episcleritis, keratitis)

Lab values

• 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
• Elevated AST, ALT, alkaline phosphatase or bilirubin above the upper limit of normal at screening
• Renal insufficiency defined by a creatinine clearance of less than 30 ml/min (CKD-EPI or MDRD formula)
• 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

Age

• Age \<18 or \>75 at screening visit

Other

• Pregnant or nursing, or women of childbearing potential unwilling to use a medically acceptable form of birth control
• Unwilling or unable to stop the use of any artificial tear formulations containing L-carnitine.
• Planned occlusion of the lacrimal puncta with either punctal plugs or cauterization during the study
• Laser-assisted in situ keratomileusis (LASIK), photorefractive keratectomy (PRK), or radial keratectomy
• The patient has a known defect in oxidative phosphorylation (such as a confirmed mitochondrial myopathy)
• Eyelid tattooing (permanent eyelining)
• On glaucoma eye-drops or eye-drops for lowering eye pressure
• Issues with closing eyelids completely or having eyelashes rub on surface of eye

• Clinician diagnosis of primary or secondary SjS.
• Positive anti-SSA
• Diagnosis of keratoconjunctivitis sicca defined by OSDI ≥ 25 and Schirmer's test ≤ 5mm/5min in at least 1 eye.
• Stable medications for past 4 weeks