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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye Disease
• Intervention / Treatment: Device: Charge-Balanced, Symmetric Nerve Stimulation; Device: Sham Stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 178
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jinho Jung, Ph.D candi.; Phone Number: +821083113509; Email: jinho.jung@nueyne.com
• Study Contact Backup: Name: PyeongHwa Eun, M.S.; Phone Number: +821095513095; Email: pyeonghwa.eun@nueyne.com

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of, 21388
    • Recruiting
    • HanGil Medical Foundation
    • Contact: Sang Mok Lee, Ph. D., MD
  • Seoul, Korea, Republic of, 07301
    • Recruiting
    • Kim's Eye Hospital
    • Contact: Kyung min Koh, Ph. D., MD
  • Seoul, Korea, Republic of, 03181
    • Recruiting
    • Department of Ophthalmology, Kangbuk Samsung Hospital
    • Contact: Chul Young Choi, Ph. D., MD
  • Seoul, Korea, Republic of, 03722
    • Recruiting
    • Department of Ophthalmology, Severance Hospital
    • Contact: Tae-im KIM, Ph. D., MD
  • Seoul, Korea, Republic of, 06192
    • Recruiting
    • Nune Eye Hospital
    • Contact: Kyoung Yoon Shin, Ph. D., MD
  • Seoul, Korea, Republic of, 06351
    • Recruiting
    • Department of Ophthalmology, Samsung Medical Center
    • Contact: Donghui Lim, Ph. D., MD.; Phone Number: +82234103569; Email: donghui.lim@samsung.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2023
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: November 2, 2023
• First Submitted That Met QC Criteria: November 2, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 2, 2023
• Last Verified: November 1, 2023

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_003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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