Dry Eye Disease
Conditions
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.
Interventions
DEVICEReal 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.
DEVICESham 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.
Sponsors
Nu Eyne Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Ocular Surface Disease Index (OSDI) score | baseline, 1, 4, 12 weeks | Check the changes in Ocular Surface Disease Index (OSDI) score |
| Changes in Tear break-up time (T-BUT) | Time Frame: baseline, 1, 4, 12 weeks | Check the changes in Tear break-up time (T-BUT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Visual Analogue Scale (VAS) score | baseline, 1 day, 3 days, 7 days | Check the changes in Visual Analogue Scale (VAS) score |
| Changes in Staining Score | baseline, 1, 4, 12 weeks | Check the changes in Staining Score |
| Changes in Matrix Metalloproteinase-9 (MMP-9) level | baseline, 4, 12 weeks | Check the changes in Matrix Metalloproteinase-9 (MMP-9) level |
| Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score) | baseline, 1, 4, 12 weeks | Check the changes in 5-Item Dry Eye Questionnaire (DEQ-5 score) |
| Changes in Tear Volume | baseline, 1, 4, 12 weeks | Check the changes in Tear Volume |
| Changes in Tear Osmolarity | baseline, 4, 12 weeks | Check the changes in Tear Osmolarity |
| Changes in the length of the aesthesiometer's filament in centimeters | baseline, 1, 4, 12 weeks | Check the changes in the length of the aesthesiometer's filament in centimeters |
| Changes in LipiView Eye Lipid Layer Thickness | baseline, 4, 12 weeks | Check the changes in LipiView Eye Lipid Layer Thickness |
| Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score | baseline, 1, 4, 12 weeks | Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score |
Countries
South Korea
Outcome results
None listed