Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery
Primary Purpose
Dry Eye Disease
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Real Pulse Electrical Stimulation (NuEyne 01)
Sham Pulse Electrical Stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Disease
Eligibility Criteria
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).)
Sites / Locations
- Department of Ophthalmology, Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Experimental Group
Control Group
Arm Description
Dry eye disease patients (n=12)
Dry eye disease patients (n=12)
Outcomes
Primary Outcome Measures
Changes in Ocular Surface Disease Index (OSDI) score
Check the changes in Ocular Surface Disease Index (OSDI) score
Changes in Tear break-up time (T-BUT)
Check the changes in Tear break-up time (T-BUT)
Secondary Outcome Measures
Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
Check the changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Changes in Visual Analogue Scale (VAS) score
Check the changes in Visual Analogue Scale (VAS) score
Changes in Staining Score
Check the changes in Staining Score
Changes in Matrix Metalloproteinase-9 (MMP-9) level
Check the changes in Matrix Metalloproteinase-9 (MMP-9) level
Changes in LipiView Eye Lipid Layer Thickness
Check the changes in LipiView Eye Lipid Layer Thickness
Changes in Tear Volume
Check the changes in Tear Volume
Changes in Tear Osmolarity
Check the changes in Tear Osmolarity
Changes in the length of the aesthesiometer's filament in centimeters
Check the changes in the length of the aesthesiometer's filament in centimeters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05271422
Brief Title
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 28, 2020 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nu Eyne Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
Dry eye disease patients (n=12)
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Dry eye disease patients (n=12)
Intervention Type
Device
Intervention Name(s)
Real Pulse Electrical Stimulation (NuEyne 01)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Pulse Electrical Stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Ocular Surface Disease Index (OSDI) score
Description
Check the changes in Ocular Surface Disease Index (OSDI) score
Time Frame
baseline, 1, 4, 12 weeks
Title
Changes in Tear break-up time (T-BUT)
Description
Check the changes in Tear break-up time (T-BUT)
Time Frame
Time Frame: baseline, 1, 4, 12 weeks
Secondary Outcome Measure Information:
Title
Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
Description
Check the changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
Time Frame
baseline, 1, 4, 12 weeks
Title
Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Description
Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Time Frame
baseline, 1, 4, 12 weeks
Title
Changes in Visual Analogue Scale (VAS) score
Description
Check the changes in Visual Analogue Scale (VAS) score
Time Frame
baseline, 1 day, 3 days, 7 days
Title
Changes in Staining Score
Description
Check the changes in Staining Score
Time Frame
baseline, 1, 4, 12 weeks
Title
Changes in Matrix Metalloproteinase-9 (MMP-9) level
Description
Check the changes in Matrix Metalloproteinase-9 (MMP-9) level
Time Frame
baseline, 4, 12 weeks
Title
Changes in LipiView Eye Lipid Layer Thickness
Description
Check the changes in LipiView Eye Lipid Layer Thickness
Time Frame
baseline, 4, 12 weeks
Title
Changes in Tear Volume
Description
Check the changes in Tear Volume
Time Frame
baseline, 1, 4, 12 weeks
Title
Changes in Tear Osmolarity
Description
Check the changes in Tear Osmolarity
Time Frame
baseline, 4, 12 weeks
Title
Changes in the length of the aesthesiometer's filament in centimeters
Description
Check the changes in the length of the aesthesiometer's filament in centimeters
Time Frame
baseline, 1, 4, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donghui Lim, Ph. D., MD.
Organizational Affiliation
Department of Ophthalmology, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery
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