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

Nu Eyne Co., Ltd.1 site in 1 country24 target enrollmentFebruary 28, 2020

ConditionsDry Eye Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye Disease
Sponsor: Nu Eyne Co., Ltd.
Enrollment: 24
Locations: 1
Primary Endpoint: Changes in Tear break-up time (T-BUT)
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 28, 2020

End Date

December 14, 2020

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nu Eyne Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Changes in Tear break-up time (T-BUT)

Time Frame: 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

Time Frame: baseline, 1, 4, 12 weeks

Check the changes in Ocular Surface Disease Index (OSDI) score

Secondary Outcomes

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 LipiView Eye Lipid Layer Thickness(baseline, 4, 12 weeks)
Changes in Matrix Metalloproteinase-9 (MMP-9) level(baseline, 4, 12 weeks)
Changes in Tear Volume(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 Tear Osmolarity(baseline, 4, 12 weeks)
Changes in the length of the aesthesiometer's filament in centimeters(baseline, 1, 4, 12 weeks)