Levocarnitine for Dry Eye in Sjogren's Syndrome

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University Medical Center

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