Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271422
• Other study ID #: NE_DED_001
• Status: Completed
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: December 14, 2020

Study information

• Verified date: February 2022
• Source: Nu Eyne Co., Ltd.
• Contact: n/a
• 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 in dry eye disease patients who are scheduled for LASEK surgery.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 14, 2020
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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).)

Related Conditions & MeSH terms

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

Intervention

Device:
• Real Pulse Electrical Stimulation (NuEyne 01)
Patients wear our clinical trial device 15~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.
• Sham Pulse Electrical Stimulation
Patients wear our clinical trial device 15~30 mins once a day for 14 days and once a week from the 15th day to the 12th week.

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Samsung Medical Center	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 Ocular Surface Disease Index (OSDI) score	Check the changes in Ocular Surface Disease Index (OSDI) score	baseline, 1, 4, 12 weeks
Primary	Changes in Tear break-up time (T-BUT)	Check the changes in Tear break-up time (T-BUT)	Time Frame: baseline, 1, 4, 12 weeks
Secondary	Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)	Check the changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)	baseline, 1, 4, 12 weeks
Secondary	Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score	Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score	baseline, 1, 4, 12 weeks
Secondary	Changes in Visual Analogue Scale (VAS) score	Check the changes in Visual Analogue Scale (VAS) score	baseline, 1 day, 3 days, 7 days
Secondary	Changes in Staining Score	Check the changes in Staining Score	baseline, 1, 4, 12 weeks
Secondary	Changes in Matrix Metalloproteinase-9 (MMP-9) level	Check the changes in Matrix Metalloproteinase-9 (MMP-9) level	baseline, 4, 12 weeks
Secondary	Changes in LipiView Eye Lipid Layer Thickness	Check the changes in LipiView Eye Lipid Layer Thickness	baseline, 4, 12 weeks
Secondary	Changes in Tear Volume	Check the changes in Tear Volume	baseline, 1, 4, 12 weeks
Secondary	Changes in Tear Osmolarity	Check the changes in Tear Osmolarity	baseline, 4, 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, 12 weeks