drugset / Trial / NCT06544447

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease With Meibomian Gland Dysfunction

NCT06544447

Phase 1/2 Recruiting 135 enrolled Beijing Tongren Hospital
RandomizedParallel-groupTriple-blindTreatment

Summary

Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease with meibomian gland dysfunction. Methods: We enrolled 270 patients at Beijing Tongren Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, OPAS, NPSI-eye, and Schirmer I expressibility and secretion score to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.

Timeline

Start
2021-06-01
Primary completion
2024-10-01
Completion
2024-10-01

Drugs

EvaluationDrugModalityDoseRoute
Background Hyaluronic Acid Other / unclassified

Indications