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.

Nu Eyne Co., Ltd.6 sites in 1 country178 target enrollmentAugust 31, 2023

ConditionsDry Eye Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Dry Eye Disease
Sponsor: Nu Eyne Co., Ltd.
Enrollment: 178
Locations: 6
Primary Endpoint: Changes in Tear break-up time (T-BUT)
Status: Recruiting
Last Updated: 2 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 after laser keratoplasty (LASEK) in patients with dry eye syndrome.

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.

Registry

clinicaltrials.gov

Start Date

August 31, 2023

End Date

August 31, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Nu Eyne Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: baseline, 12 weeks

Check the changes in Tear break-up time (T-BUT)

Changes in Visual Analogue Scale (VAS) score

Time Frame: baseline, 1 week

Check the changes in Visual Analogue Scale (VAS) score

Secondary Outcomes

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 Tear Volume(baseline, 1, 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)