NCT05203796

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

A Single-centered, Double-blinded, Placebo/Sham-controlled, Randomized Exploratory Clinical Trial to Evaluate the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Mild- or Moderate-level Dry Eye Disease Using NuEyne 02 (Personal Stimulator)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Nu Eyne Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Duration of study period(per participant): Screening period (0-4weeks), Intervention period (5weeks). Patient needs to visit site at least 3 times (Screening, V4, V6), V2 can be done with screening visit. The clinical trial device performs a personal electrical stimulator around the eyes and peripheral nerves for 28 days (7 times/week, 30 minutes each time). During the study period, dry eye examination and treatment methods (only eye drops provided in clinical trials are applied) are carried out in the same way.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-08-23
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2022-01-24
• Last updated: 2022-02-09

Locations

1 site across 1 country: South Korea