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Can a common supplement soothe Sjogren's dry eye?

NCT ID NCT03953703

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This small study tested whether levocarnitine, a natural substance, can help treat dry eye in adults with Sjogren's syndrome. Fifteen participants received both the drug and a placebo in a crossover design. The goal was to see if levocarnitine reduces eye inflammation and improves symptoms like dryness and discomfort.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

15 people

The number who actually took part.

Started

Nov 2021

Finished

Sep 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.