NCT06120348

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
178

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 2, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

November 13, 2023

Status Verified

November 1, 2023

Enrollment Period

8 months

First QC Date

November 2, 2023

Last Update Submit

November 8, 2023

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (6)

  • 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

    baseline, 1, 4, 8, 12 weeks

  • Changes in Visual Analogue Scale (VAS) score

    baseline, 3 days, 4, 8, 12 weeks

  • Changes in Staining Score

    baseline, 1, 4, 8, 12 weeks

  • Changes in the length of the aesthesiometer's filament in centimeters

    baseline, 1, 4, 8, 12 weeks

  • +1 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

SHAM COMPARATOR

Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.

Device: Sham Stimulation

Interventions

Charge-Balanced, Symmetric Nerve StimulationDEVICE

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.

Experimental Group
Sham StimulationDEVICE

Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.

Control Group

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HanGil Medical Foundation

Incheon, 21388, South Korea

RECRUITING

Department of Ophthalmology, Kangbuk Samsung Hospital

Seoul, 03181, South Korea

RECRUITING

Department of Ophthalmology, Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Nune Eye Hospital

Seoul, 06192, South Korea

RECRUITING

Department of Ophthalmology, Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Kim's Eye Hospital

Seoul, 07301, South Korea

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Dong Hui Lim, Ph. D., MD

    Department of Ophthalmology, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinho Jung, Ph.D Candi.

CONTACT

+821083113509jinho.jung@nueyne.com

PyeongHwa Eun, M.S.

CONTACT

+821095513095pyeonghwa.eun@nueyne.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2023

First Posted

November 7, 2023

Study Start

August 31, 2023

Primary Completion

April 30, 2024

Study Completion

August 31, 2024

Last Updated

November 13, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(6)