Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) Surgery

Dry Eye Disease Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06120348
• Other study ID #: NE_DED_003
• Status: Recruiting
• Phase: N/A
• Start date: August 31, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: November 2023
• Source: Nu Eyne Co., Ltd.
• Contact: Jinho Jung, Ph.D Candi.
• Phone: +821083113509
• Email: jinho.jung[@]nueyne.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 178
• Est. completion date: August 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Device:
• Charge-Balanced, Symmetric Nerve Stimulation
Charge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
• Sham Stimulation
Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.

Locations

Country	Name	City	State
Korea, Republic of	HanGil Medical Foundation	Incheon
Korea, Republic of	Department of Ophthalmology, Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Department of Ophthalmology, Samsung Medical Center	Seoul
Korea, Republic of	Department of Ophthalmology, Severance Hospital	Seoul
Korea, Republic of	Kim's Eye Hospital	Seoul
Korea, Republic of	Nune Eye Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Nu Eyne Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Tear break-up time (T-BUT)	Check the changes in Tear break-up time (T-BUT)	baseline, 12 weeks
Primary	Changes in Visual Analogue Scale (VAS) score	Check the changes in Visual Analogue Scale (VAS) score	baseline, 1 week
Secondary	Changes in Tear break-up time (T-BUT)	Check the changes in Tear break-up time (T-BUT)	baseline, 1, 4, 8 weeks
Secondary	Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score	Check the changes in 5-Item Dry Eye Questionnaire Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease (OSDI) score	baseline, 1, 4, 8, 12 weeks
Secondary	Changes in Visual Analogue Scale (VAS) score	Check the changes in Visual Analogue Scale (VAS) score	baseline, 3 days, 4, 8, 12 weeks
Secondary	Changes in Staining Score	Check the changes in Staining Score	baseline, 1, 4, 8, 12 weeks
Secondary	Changes in the length of the aesthesiometer's filament in centimeters	Check the changes in the length of the aesthesiometer's filament in centimeters	baseline, 1, 4, 8, 12 weeks
Secondary	Changes in Tear Volume	Check the changes in Tear Volume	baseline, 1, 4, 8, 12 weeks