Clinical trial NCT06120348: Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) Surgery
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: Nu Eyne Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-07
Enrollment: 178
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 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.

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
* 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
* Those who participated in other clinical trial within 30 days from the screening date

Primary outcomes:
measure: Changes in Tear break-up time (T-BUT)
timeFrame: baseline, 12 weeks
measure: Changes in Visual Analogue Scale (VAS) score
timeFrame: baseline, 1 week
Secondary outcomes:
measure: Changes in Tear break-up time (T-BUT)
timeFrame: baseline, 1, 4, 8 weeks
measure: Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score
timeFrame: baseline, 1, 4, 8, 12 weeks
measure: Changes in Visual Analogue Scale (VAS) score
timeFrame: baseline, 3 days, 4, 8, 12 weeks
measure: Changes in Staining Score
timeFrame: baseline, 1, 4, 8, 12 weeks
measure: Changes in the length of the aesthesiometer's filament in centimeters
timeFrame: baseline, 1, 4, 8, 12 weeks
measure: Changes in Tear Volume
timeFrame: baseline, 1, 4, 8, 12 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: HanGil Medical Foundation
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Nune Eye Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Ophthalmology, Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Kim's Eye Hospital
Study officials:
affiliation: Department of Ophthalmology, Samsung Medical Center
name: Dong Hui Lim, Ph. D., MD
role: PRINCIPAL_INVESTIGATOR
References: