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
Verified date | February 2022 |
Source | Nu Eyne Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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).) |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Department of Ophthalmology, Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Nu Eyne Co., Ltd. |
Korea, Republic of,
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 |
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