Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

Capital Medical University

Status and phase: Enrolling; Phase 2

Conditions: Dry Eye Disease

Treatments: Drug: Hyaluronic acid eye drops; Device: Transcutaneous Auricular Vagus Nerve Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT04673643

taVNS-DED-2020

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

taVNS group

Experimental group

Description:

taVNS device (Elmmedicare, EC100, Shenzhen, China) was used to apply stimulation for patients. Stimulation parameters comprised an electrical current of 1 mA at a frequency of 20 Hz, with a waveform width of 1 ms. Repurposed off-the-shelf devices were utilized for this purpose, with the stimulator generating single square-wave pulses lasting 1 ms each. Enhancing conductivity was achieved by wiping the ear with tap water. The electrodes were placed on the cymba conchae and concha around the affected ear, which is the region of rich vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Drug: Hyaluronic acid eye drops

Control Group

Placebo Comparator group

Description:

taVNS device were applied using the same stimulator, stimulation parameters and same sessions. However, the electrodes were placed on the antihelix around the affected ear, which is the region of few vagus nerve branch distribution. Drug: Hyaluronic acid eye drops Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.

Treatment:

Device: Transcutaneous Auricular Vagus Nerve Stimulation

Drug: Hyaluronic acid eye drops