NCT06120348

Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) Surgery

Multi-center, Placebo-controlled, Randomized, Parallel Design, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Application of Electrical Stimulation Around Eye After Laser Keratoplasty (LASEK) in Patients With Dry Eye Syndrome.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 178 (estimated)
• 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 after laser keratoplasty (LASEK) in patients with dry eye syndrome.

Detailed description

Duration of study period (per participant): Screening period (0-4weeks). Intervention period (12weeks). Patient needs to visit site at least 8 times (Screening, baseline, 1 day, 3day, 1, 4, 8, 12weeks based on baseline). Baseline visit will be done on the day of surgery.

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	Charge-Balanced, Symmetric Nerve Stimulation	Charge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
DEVICE	Sham Stimulation	Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.

Timeline

• Start date: 2023-08-31
• Primary completion: 2024-04-30
• Completion: 2024-08-31
• First posted: 2023-11-07
• Last updated: 2023-11-13

Locations

6 sites across 1 country: South Korea