NCT04673643 Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease
| NCT ID | NCT04673643 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beijing Tongren Hospital |
| Condition | Dry Eye Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2021-07-01 |
| Primary Completion | 2024-10-01 |
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.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 128 participants in total. It began in 2021-07-01 with a primary completion date of 2024-10-01.
⚠ 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 with meibomian gland dysfunction. Methods: We enrolled 256 patients at Beijing Tongren Hospital. Patients completed questionnaires at baseline, 1 month, 3 months, and 6 months.OSDI score, TBUT, Schirmer I, tCFS, MGD score, 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 \<=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.
Contact & Investigator
Haihong Lian, Doc
PRINCIPAL INVESTIGATOR
BeijingTongren Hospital, Capital Medical University
Frequently Asked Questions
Who can join the NCT04673643 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.
What phase is the NCT04673643 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04673643 currently recruiting?
Yes, NCT04673643 is actively recruiting participants. Contact the research team at wudong0120@outlook.com for enrollment information.
Where is the NCT04673643 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China.
Who is sponsoring the NCT04673643 clinical trial?
NCT04673643 is sponsored by Beijing Tongren Hospital. The principal investigator is Haihong Lian, Doc at BeijingTongren Hospital, Capital Medical University. The trial plans to enroll 128 participants.