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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Dry Eye Disease

Intervention / Treatment
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* Device: Charge-Balanced, Symmetric Nerve Stimulation
* Device: Sham Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women aged 19 to 60 Those who are scheduled to get LASEK surgery Those who have had dry eye symptoms for more than 3 months. According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher Those who TBUT test results of less than 10 seconds Those who OSDI score of 13 or higher Those who agreed to use contraception using a medically acceptable method during the period of clinical trial among Women of child bearing potential (WOCBP). A person who voluntarily agreed to participate in this clinical trial. Exclusion Criteria: A person who has applied cyclosporin for the treatment of dry eye syndrome, drugs such as lipid-containing eye drops, topical steroid eye drops, IPL, etc., and medical devices for the treatment of dry eye syndrome within one month from the screening A person with an uncontrollable systemic chronic disease. 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, Punctal plug insertion, Pterygium surgery) 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 A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin) 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).) Those who wore contact lenses within 72 hours before screening or who must wear contact lenses during the clinical trial period Those who have taken the relevant systemic drugs (steroids, immunosuppressants, omega-3 and anticholinergic drugs, etc.) within 30 days from the date of screening Those who are judged to have problems attaching electrodes due to inflammatory reactions or other dermatological problems in the skin around the orbit where the electrodes of medical devices are attached Those who participated in other clinical trial within 30 days from the screening date

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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: Charge-Balanced, Symmetric Nerve Stimulation<br>* 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.<br>|
| Sham Comparator: Control Group<br>Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. | Device: Sham Stimulation<br>* Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Tear break-up time (T-BUT) | Check the changes in Tear break-up time (T-BUT) | baseline, 12 weeks | 
| Changes in Visual Analogue Scale (VAS) score | Check the changes in Visual Analogue Scale (VAS) score | baseline, 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Tear break-up time (T-BUT) | Check the changes in Tear break-up time (T-BUT) | baseline, 1, 4, 8 weeks | 
| Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score | Check the changes in 5-Item Dry Eye Questionnaire Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease (OSDI) score | baseline, 1, 4, 8, 12 weeks | 
| Changes in Visual Analogue Scale (VAS) score | Check the changes in Visual Analogue Scale (VAS) score | baseline, 3 days, 4, 8, 12 weeks | 
| Changes in Staining Score | Check the changes in Staining Score | baseline, 1, 4, 8, 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, 8, 12 weeks | 
| Changes in Tear Volume | Check the changes in Tear Volume | baseline, 1, 4, 8, 12 weeks |