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

Not Applicable

Completed

• Conditions: Dry Eye Disease
• Interventions: Device: Sham Pulse Electrical Stimulation; Device: Real Pulse Electrical Stimulation (NuEyne 01)

• Registration Number: NCT05271422
• Lead Sponsor: Nu Eyne Co., Ltd.

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.

Study Timeline

• Study Start: 2020-02-28
• Primary Completion: 2020-12-14
• Study Completion: 2020-12-14
• Status Verified: 2022-02
• Study First Submitted: 2022-02-25
• Study First Submitted QC: 2022-03-07
• Last Update Submitted: 2022-03-07
• Study First Posted: 2022-03-09
• Last Update Posted: 2022-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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).)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Sham Pulse Electrical Stimulation	Dry eye disease patients (n=12)
Experimental Group	Real Pulse Electrical Stimulation (NuEyne 01)	Dry eye disease patients (n=12)

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Ophthalmology, Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of