NCT06696625 Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye
| NCT ID | NCT06696625 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tongren Hospital |
| Condition | Dry Eye Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2025-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2021-07-01 with a primary completion date of 2025-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Objective: To evaluate the effect of transcutaneous auricular vagus nerve stimulation (taVNS) for the patients with dry eye disease. Methods: The investigators enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months. OSDI score, TBUT, Schirmer I, CFS, SF36, DEQ5, and psychological status to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06696625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Dry Eye Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06696625 currently recruiting?
Yes, NCT06696625 is actively recruiting participants. Contact the research team at wudong0120@outlook.com for enrollment information.
Where is the NCT06696625 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06696625 clinical trial?
NCT06696625 is sponsored by Beijing Tongren Hospital. The trial plans to enroll 256 participants.