Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT03953703
Eligibility 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03953703
Study Brief:
Protocol Section:
NCT03953703