Using a non-invasive method to stimulate the vagus nerve for treating dry eye disease

Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye: a Randomized Clinical Trial

This study is testing a new non-invasive way to stimulate the vagus nerve to see if it can help people with dry eye disease feel better.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 256 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Beijing Tongren Hospital (other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06696625 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of transcutaneous auricular vagus nerve stimulation (taVNS) on patients suffering from dry eye disease. A total of 256 patients will be enrolled at Beijing Tongren Hospital and will complete various questionnaires to assess their symptoms and eye health at baseline, and at 1, 3, and 6 months post-treatment. The study will measure outcomes using several validated scales, including the Ocular Surface Disease Index (OSDI) and tear film breakup time (TBUT). Statistical significance will be determined with 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 65 who have experienced dry eye symptoms for at least six months.

Not a fit: Patients with systemic autoimmune diseases, ocular malignancies, or active infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a new non-invasive treatment option for patients with dry eye disease.

How similar studies have performed: While the use of taVNS is a novel approach in this context, similar studies have shown promising results in other conditions, suggesting potential for success.

Eligibility criteria

Inclusion Criteria:

1. Age \>=18 and Age \<=65.
2. complaint of DED symptoms for 6 months or longer at screening.
3. ocular surface disease index (OSDI) score of 25 or higher.
4. tear film breakup time (TFBUT) of 5 seconds or less.
5. Schirmer I test without anesthesia of 5 mm or more at 5 minutes.
6. tCFS score of 4 or higher.

Exclusion Criteria:

1. History systemic autoimmune diseases and ocular/periocular malignancy.
2. Clinically relevant slitlamp findings or abnormal lid anatomy.
3. Active ocular allergies and active infection.
4. Pregnant or lactating women.

Where this trial is running

Beijing, Beijing Municipality

• China Beijing TongRen Hospital, Capital Medical University Beijing, China — Beijing, Beijing Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Dong Wu, Doctor

Conditions: Dry Eye Disease, taVNS, Dry eye, RCT