NCT05271422

Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery

A Single Center, Single-blind, Exploratory Study to Evaluate the Efficacy and Safety of the Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for LASEK Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Nu Eyne Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eye in dry eye disease patients who are scheduled for LASEK surgery.

Detailed description

Duration of study period (per participant): Screening period (0-14 days), Intervention period (12 weeks), F/U period (2 weeks) Patient needs to visit site at least 9 times (Screening, baseline, V1, V2, V3, Tele-visit, V4, V5, F/U Tele-visit). Baseline visit will be done on the day of surgery. Visit 1, 2, 3, Tele-visit, 4, 5, F/U Tele-visit is 1 day, 3 days, 1 weeks, 2 weeks, 4 weeks, 12 weeks and 16weeks after baseline visit.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	Real Pulse Electrical Stimulation (NuEyne 01)	Patients wear our clinical trial device 15\~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.
DEVICE	Sham Pulse Electrical Stimulation	Patients wear our clinical trial device 15\~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.

Timeline

• Start date: 2020-02-28
• Primary completion: 2020-12-14
• Completion: 2020-12-14
• First posted: 2022-03-09
• Last updated: 2022-03-09

Locations

1 site across 1 country: South Korea