Applying pulse electrical stimulation around the eye for dry eye disease patients undergoing LASEK surgery
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.
This study is testing if using pulse electrical stimulation around the eye can help people with dry eye feel better after having LASEK surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 178 (estimated) |
| Ages | 19 Years to 60 Years |
| Sex | All |
| Sponsor | Nu Eyne Co., Ltd. Industry-sponsored |
| Locations | 6 sites (Incheon and 5 other locations) |
| Trial ID | NCT06120348 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of pulse electrical stimulation applied around the eye in patients with dry eye disease who are scheduled for laser epithelial keratomileusis (LASEK) surgery. Participants will undergo a screening period followed by an intervention period lasting 12 weeks, during which they will visit the study site at least eight times for assessments and treatment. The interventions include charge-balanced symmetric nerve stimulation and sham stimulation to compare effects on dry eye symptoms post-surgery.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 19 to 60 with chronic dry eye symptoms and scheduled for LASEK surgery.
Not a fit: Patients who have recently used specific treatments for dry eye syndrome or have uncontrolled systemic chronic diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate dry eye symptoms in patients undergoing LASEK surgery.
How similar studies have performed: While similar approaches have been explored, this specific application of pulse electrical stimulation in conjunction with LASEK surgery is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Incheon and 5 other locations
- HanGil Medical Foundation — Incheon, Korea, Republic of (Recruiting)
- Department of Ophthalmology, Kangbuk Samsung Hospital — Seoul, Korea, Republic of (Recruiting)
- Department of Ophthalmology, Severance Hospital — Seoul, Korea, Republic of (Recruiting)
- Nune Eye Hospital — Seoul, Korea, Republic of (Recruiting)
- Department of Ophthalmology, Samsung Medical Center — Seoul, Korea, Republic of (Recruiting)
- Kim's Eye Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Dong Hui Lim, Ph. D., MD — Department of Ophthalmology, Samsung Medical Center
- Study coordinator: Jinho Jung, Ph.D Candi.
- Email: jinho.jung@nueyne.com
- Phone: +821083113509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.