Levocarnitine for Dry Eye in Sjogren's Syndrome

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · May 14, 2019

Keywords

ClinConnect Summary

This clinical trial is investigating whether levocarnitine can help reduce dry eye symptoms in adults with Sjogren's syndrome, a condition that affects the body's ability to produce moisture. Participants in the study will receive both levocarnitine and a placebo (a treatment that looks like the real thing but has no active ingredients) in a crossover design, meaning everyone will have a chance to try both treatments. The trial is currently looking for participants aged 18 to 75 who have been diagnosed with Sjogren's syndrome and have specific dry eye symptoms.

To join the study, individuals must have a confirmed diagnosis of Sjogren's syndrome and experience significant dry eye symptoms. However, there are some criteria that might exclude someone from participating, such as recent eye surgery, certain medical conditions, or using specific eye drops. Participants can expect to undergo regular assessments of their eye health and symptoms throughout the study. It’s important to note that those interested will need to stop using certain eye treatments and supplements for a month before and during the study. This trial aims to provide valuable information about a potential new treatment for dry eye in people with Sjogren's syndrome.

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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
• • 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