Levocarnitine for Dry Eye in Sjogren's Syndrome

NCT03953703 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: irb200020
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sjogren's Syndrome; Keratoconjunctivitis Sicca

Keywords

Sjogren's syndrome, dry eye, sicca

Outcome Measures

Primary Outcomes (1)

• Mean change in tear inflammatory cytokine milieu

  Levels of inflammatory cytokines IFN-gamma, TNF-alpha, IL-17, IL-6 and IL-1beta will be measured by flow cytometric multiplexed bead assay.

  14 weeks

Secondary Outcomes (10)

• Ocular Surface Disease Index (OSDI)

  14 weeks

• Mean change in tear carnitine levels.

  14 weeks

• EULAR Sjogren's Disease Activity Index

  14 weeks

• EULAR Sjogren's Syndrome Patient Reported Index

  14 weeks

• EULAR Sicca Score

  14 weeks

Study Arms (2)

Experimental: Levocarnitine, Placebo

EXPERIMENTAL

1000 mg of levocarnitine twice per day for six weeks, a two week washout period, 1000 mg of placebo twice per day for 6 weeks

Drug: Levocarnitine; Drug: Placebo

Experimental: Placebo, Levocarnitine

EXPERIMENTAL

1000 mg of placebo twice per day for six weeks, a two week washout period, 1000 mg of levocarnitine twice per day for 6 weeks

Drug: Levocarnitine; Drug: Placebo

Interventions

Levocarnitine DRUG

Levocarnitine 1000 mg twice per day for 6 weeks

Experimental: Levocarnitine, Placebo; Experimental: Placebo, Levocarnitine

Placebo DRUG

Placebo 1000 mg twice per day for 6 weeks

Experimental: Levocarnitine, Placebo; Experimental: Placebo, Levocarnitine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Ocular surgery/trauma in the last 6 months or planned during the study
• 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
• 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)
• Treatment with any investigational agent within ≤ 4 weeks (or 5 half-lives of the investigational drug, whichever is longer) of the screening visit
• 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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Keratoconjunctivitis Sicca; Dry Eye Syndromes

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Christine Shieh, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Ophthalmology

Study Record Dates

• First Submitted: April 30, 2019
• First Posted: May 16, 2019
• Study Start: November 17, 2021
• Primary Completion: September 19, 2025
• Study Completion: September 19, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Locations

US (1)