Clinical trial NCT05271422: Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Nu Eyne Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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
* 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).)

Primary outcomes:
measure: Changes in Ocular Surface Disease Index (OSDI) score
timeFrame: baseline, 1, 4, 12 weeks
measure: Changes in Tear break-up time (T-BUT)
timeFrame: Time Frame: baseline, 1, 4, 12 weeks
Secondary outcomes:
measure: Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
timeFrame: baseline, 1, 4, 12 weeks
measure: Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
timeFrame: baseline, 1, 4, 12 weeks
measure: Changes in Visual Analogue Scale (VAS) score
timeFrame: baseline, 1 day, 3 days, 7 days
measure: Changes in Staining Score
timeFrame: baseline, 1, 4, 12 weeks
measure: Changes in Matrix Metalloproteinase-9 (MMP-9) level
timeFrame: baseline, 4, 12 weeks
measure: Changes in LipiView Eye Lipid Layer Thickness
timeFrame: baseline, 4, 12 weeks
measure: Changes in Tear Volume
timeFrame: baseline, 1, 4, 12 weeks
measure: Changes in Tear Osmolarity
timeFrame: baseline, 4, 12 weeks
measure: Changes in the length of the aesthesiometer's filament in centimeters
timeFrame: baseline, 1, 4, 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Samsung Medical Center
Study officials:
affiliation: Department of Ophthalmology, Samsung Medical Center
name: Donghui Lim, Ph. D., MD.
role: PRINCIPAL_INVESTIGATOR
References: