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

Study Overview
=================
Brief 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.

Official Title
-----------------
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

Conditions
-----------------
Dry Eye Disease

Intervention / Treatment
-----------------
* Device: Real Pulse Electrical Stimulation (NuEyne 01)
* Device: Sham Pulse Electrical Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants must be 19 to 60 years of age, at the time of screening Those who are scheduled to get LASEK surgery According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher Those with an OSDI score of 13 or higher A person who has no pregnancy plan during the clinical trial period and has agreed to an effective contraceptive plan for Women of child bearing potential (WOCBP) by a doctor A person who voluntarily agreed to participate in this clinical trial Exclusion Criteria: Patients who meet any of the exclusion criteria are excluded from this clinical trial. A person with an uncontrollable systemic chronic disease (diabetes mellitus) Those who are allergic to drugs such as Fluorescein Solution or ophthalmic anesthetics In a case where there is a history of receiving ophthalmic surgery known to affect the tear layer within the last 6 months (e.g., Cataract, Pterygium surgery) A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin) A person who has eyelid diseases or structural abnormalities A person with acute eye infection or inflammation of the eyeball not related to Meibomian gland dysfunction A person with abnormalities in the eyelids or eyelashes A person with an eye condition or ophthalmic disease that is considered unsuitable for surgery (e.g., detachment of the retina, cataract) Pregnant or lactating women Those who can't understand or read the consent form of this clinical trial (e.g., illiterate or foreigners) Any other cases that PI considers hard to participate in this clinical trial (e.g., heart-related problems, seizure, epilepsy. Patients transplanted metal or electronic device in head & neck. Patient suffering from unknown pain. Patients who are warned not to use our clinical trial device or is prohibited from using it (e.g., pacemaker user).)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Dry eye disease patients (n=12) | Device: Real Pulse Electrical Stimulation (NuEyne 01)<br>* 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.<br>|
| Sham Comparator: Control Group<br>Dry eye disease patients (n=12) | Device: Sham Pulse Electrical Stimulation<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Ocular Surface Disease Index (OSDI) score | Check the changes in Ocular Surface Disease Index (OSDI) score | baseline, 1, 4, 12 weeks | 
| Changes in Tear break-up time (T-BUT) | Check the changes in Tear break-up time (T-BUT) | Time Frame: baseline, 1, 4, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score) | Check the changes in 5-Item Dry Eye Questionnaire (DEQ-5 score) | baseline, 1, 4, 12 weeks | 
| Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score | Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score | baseline, 1, 4, 12 weeks | 
| Changes in Visual Analogue Scale (VAS) score | Check the changes in Visual Analogue Scale (VAS) score | baseline, 1 day, 3 days, 7 days | 
| Changes in Staining Score | Check the changes in Staining Score | baseline, 1, 4, 12 weeks | 
| Changes in Matrix Metalloproteinase-9 (MMP-9) level | Check the changes in Matrix Metalloproteinase-9 (MMP-9) level | baseline, 4, 12 weeks | 
| Changes in LipiView Eye Lipid Layer Thickness | Check the changes in LipiView Eye Lipid Layer Thickness | baseline, 4, 12 weeks | 
| Changes in Tear Volume | Check the changes in Tear Volume | baseline, 1, 4, 12 weeks | 
| Changes in Tear Osmolarity | Check the changes in Tear Osmolarity | baseline, 4, 12 weeks | 
| Changes in the length of the aesthesiometer's filament in centimeters | Check the changes in the length of the aesthesiometer's filament in centimeters | baseline, 1, 4, 12 weeks |