Levocarnitine for Dry Eye in Sjogren's Syndrome

• Register: ClinicalTrials.gov
• Last refreshed on: 18 March 2024
• Main ID: NCT03953703
• Date of registration: 30/04/2019
• Prospective Registration: Yes
• Primary sponsor: Vanderbilt University Medical Center
• Public title: Levocarnitine for Dry Eye in Sjogren's Syndrome
• Scientific title: A Randomized Placebo-controlled, Double Blind Pilot Crossover Trial of Levocarnitine for the Treatment of Keratoconjunctivitis Sicca in Sjogren's Syndrome
• Date of first enrolment: November 17, 2021
• Target sample size: 15
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT03953703
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Jonathan M Williams, PhD

• Name: Jonathan M WIlliams, PhD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Sjogren's Syndrome

Keratoconjunctivitis Sicca

Intervention(s)

Drug: Levocarnitine

Drug: Placebo

Primary Outcome(s)

Mean change in tear inflammatory cytokine milieu [Time Frame: 14 weeks]

Secondary Outcome(s)

Mean change in tear carnitine levels. [Time Frame: 14 weeks]

EULAR Sjogren's Disease Activity Index [Time Frame: 14 weeks]

Fluorescein staining [Time Frame: 14 weeks]

Schirmer's tear test [Time Frame: 14 weeks]

EULAR Sjogren's Syndrome Patient Reported Index [Time Frame: 14 weeks]

Lissamine green staining [Time Frame: 14 weeks]

Tear break-up time [Time Frame: 14 weeks]

Ocular Surface Disease Index (OSDI) [Time Frame: 14 weeks]

EULAR Sicca Score [Time Frame: 14 weeks]

Patient Global Assessment [Time Frame: 14 weeks]

Secondary ID(s)

irb200020

Source(s) of Monetary Support

Please refer to primary and secondary sponsors