Using a non-invasive method to stimulate the vagus nerve for treating dry eye disease
Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease: A Randomized Clinical Trial
This study is testing a new non-invasive method to stimulate the vagus nerve to see if it can help people with dry eye disease feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Beijing Tongren Hospital Academic / other |
| Locations | 2 sites (Beijing and 1 other locations) |
| Trial ID | NCT04673643 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) in patients suffering from dry eye disease associated with meibomian gland dysfunction. A total of 256 participants will be enrolled at Beijing Tongren Hospital, where they will complete various questionnaires and assessments at baseline and follow-up intervals of 1, 3, and 6 months. The study aims to measure therapeutic effects using scores related to dry eye symptoms and psychological status, with statistical significance defined as a p-value of less than 0.05.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a clinical diagnosis of dry eye disease.
Not a fit: Patients with a history of depression, tumors, thyroid disease, diabetes, cardiac diseases, or those who have undergone ophthalmology surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, non-invasive treatment option for patients with dry eye disease.
How similar studies have performed: While the use of vagus nerve stimulation is gaining interest, this specific application for dry eye disease is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age \>=18 and Age \<=75. 2. Clinical diagnosis of dry eye disease. Exclusion Criteria: 1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases. 2. History of phthalmology surgery. 3. Pregnant or lactating women.
Where this trial is running
Beijing and 1 other locations
- Beijing Tongren Hospital — Beijing, China (Recruiting)
- Wu Dong — Beijing, China (Completed)
Study contacts
- Principal investigator: Haihong Lian, Doc — BeijingTongren Hospital, Capital Medical University
- Study coordinator: Dong Wu
- Email: wudong0120@outlook.com
- Phone: 8615810333520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.