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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Device: Real Pulse Electrical Stimulation (NuEyne 01); Device: Sham Pulse Electrical Stimulation

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06351
    • Department of Ophthalmology, Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental Group; Dry eye disease patients (n=12)	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.
SHAM_COMPARATOR: Control Group; Dry eye disease patients (n=12)	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.

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

Collaborators and Investigators

• Sponsor: Nu Eyne Co., Ltd.
• Investigators: Principal Investigator: Donghui Lim, Ph. D., MD., Department of Ophthalmology, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 28, 2020
• Primary Completion (ACTUAL): December 14, 2020
• Study Completion (ACTUAL): December 14, 2020

Study Registration Dates

• First Submitted: February 25, 2022
• First Submitted That Met QC Criteria: March 7, 2022
• First Posted (ACTUAL): March 9, 2022

Study Record Updates

• Last Update Posted (ACTUAL): March 9, 2022
• Last Update Submitted That Met QC Criteria: March 7, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: NE_DED_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No