CompletedPhase 2

Levocarnitine for Dry Eye in Sjogren's Syndrome

United States15 participantsStarted 2021-11-17

Plain-language summary

This study evaluates the effectiveness of levocarnitine in the treatment of dry eye in adults with Sjogren's syndrome. This will be a crossover study design with all participants receiving both levocarnitine and placebo.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Age \<18 or \>75 at screening visit
✕. 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.
✕. Taking any form of levocarnitine supplementation or nutritional supplements containing L-carnitine within 2 months prior to enrollment
✕. 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
✕. Unwilling to discontinue wearing contact lenses for 1 month prior and throughout the duration of the study
✕. 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

What they're measuring

Mean change in tear inflammatory cytokine milieu

Timeframe: 14 weeks

Trial details

NCT IDNCT03953703

SponsorVanderbilt University Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-19

View on ClinicalTrials.gov More Sjogren's Syndrome trials