Transcutaneous Auricular Vagus Nerve Stimulation in Dry Eye Disease

NCT04673643 | Recruiting Phase 2

• 1 other identifier: taVNS-DED-2020
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 2

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.

Conditions

Dry Eye Disease

Keywords

taVNS; Dry eye; RCT

Outcome Measures

Primary Outcomes (1)

• OSDI

  Ocular Surface Disease Index (OSDI) questionnaire: The OSDI questionnaire is designed to assess the severity of symptoms and the impact of ocular surface diseases, such as dry eye disease, on a patient's quality of life.

  Baseline, month 1, 3, and 6

Secondary Outcomes (5)

• TBUT

  Baseline, month 1, 3, and 6

• Schirmerl

  Baseline, month 1, 3, and 6

• Corneal fluorescein staining (tCFS)

  Baseline, month 1, 3, and 6

• Meibomian Gland Dysfunction Score

  Baseline, month 1, 3, and 6

• Psychological status

  Baseline, month 3, 6 and 12

Study Arms (2)

taVNS group

EXPERIMENTAL

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.

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

Control Group

PLACEBO COMPARATOR

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.

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

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation DEVICE

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. Patients in control group 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.

Control Group; taVNS group

Hyaluronic acid eye drops DRUG

Participants in both groups received hyaluronic acid eye drops (HYLO COMOD® eye drops, Ursapharm, Ltd., Germany) with the treatment of 3 times a day.

Control Group; taVNS group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 and Age \<=75.
• Clinical diagnosis of dry eye disease.

You may not qualify if:

• History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
• History of phthalmology surgery.
• Pregnant or lactating women.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (2)

Beijing Tongren Hospital

Beijing, China

RECRUITING

Wu Dong

Beijing, China

COMPLETED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Haihong Lian, Doc

  BeijingTongren Hospital, Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dong Wu

CONTACT

8615810333520; wudong0120@outlook.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Transcutaneous Auricular Vagus Nerve Stimulation

Study Record Dates

• First Submitted: December 10, 2020
• First Posted: December 17, 2020
• Study Start: July 1, 2021
• Primary Completion: October 1, 2024
• Study Completion: October 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (2)