Dry Eye Disease Clinical Trial
Official title:
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)
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.
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. ;
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