NCT05271422

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 28, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 9, 2022

Completed
Last Updated

March 9, 2022

Status Verified

February 1, 2022

Enrollment Period

10 months

First QC Date

February 25, 2022

Last Update Submit

March 7, 2022

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • 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

    baseline, 1, 4, 12 weeks

  • Changes in Visual Analogue Scale (VAS) score

    baseline, 1 day, 3 days, 7 days

  • Changes in Staining Score

    baseline, 1, 4, 12 weeks

  • Changes in Matrix Metalloproteinase-9 (MMP-9) level

    baseline, 4, 12 weeks

  • +4 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

Dry eye disease patients (n=12)

Device: Real Pulse Electrical Stimulation (NuEyne 01)

Control Group

SHAM COMPARATOR

Dry eye disease patients (n=12)

Device: Sham Pulse Electrical Stimulation

Interventions

Real Pulse Electrical Stimulation (NuEyne 01)DEVICE

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.

Experimental Group
Sham Pulse Electrical StimulationDEVICE

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.

Control Group

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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).)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Officials

  • Donghui Lim, Ph. D., MD.

    Department of Ophthalmology, Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 25, 2022

First Posted

March 9, 2022

Study Start

February 28, 2020

Primary Completion

December 14, 2020

Study Completion

December 14, 2020

Last Updated

March 9, 2022

Record last verified: 2022-02

Locations

KR(1)