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The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Dry Eye Disease

NCT05203796 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-02-09

No results posted yet for this study

Summary

The purpose of this study is to investigate the safety and effectiveness for applying the electrical stimulation transcutaneously around the eyes and peripheral nerves nearby. The outcomes are compared between the patients with mild- or moderate-level dry eye disease using the real electrical stimulator and the sham electrical stimulator.

Conditions

Interventions

DEVICE

Transcutaneous pulsed electrical stimulation (NuEyne 02)

Arm 1: Experimental: Experimental group: Dry eye disease patients (n=12) Device: Pulse Electrical Stimulation Pulse Electrical Stimulation: Patients wear our clinical trial device 30mins once a day for 4 weeks.

DEVICE

Sham stimulation

Arm 2: Sham Comparator: Comparison group: Dry eye disease patients (n=12) Device: Sham stimulation Sham stimulation: Patients wear our clinical trial device 30mins once a day for 4 weeks.

Sponsors & Collaborators

  • Nu Eyne Co., Ltd.

    lead INDUSTRY

Principal Investigators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-23
Primary Completion
2022-01-26
Completion
2022-01-26

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05203796 on ClinicalTrials.gov