Dry Eye DiseaseNCT05271422
Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Scheduled for LASEK Surgery
A study testing Real Pulse Electrical Stimulation (NuEyne 01) in people with Dry Eye Disease, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Real Pulse Electrical Stimulation (NuEyne 01)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Feb 2020to 14 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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).)
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Ophthalmology, Samsung Medical Center
Seoul, 06351
About this study
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
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.
Read the 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.
- Conditions
- Dry Eye Disease
- Being tested
- Real Pulse Electrical Stimulation (NuEyne 01), Sham Pulse Electrical Stimulation
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Pulse Electrical Stimulation (NuEyne 01)Device
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Dry eye disease patients (n=12) Receives: Device: Real Pulse Electrical Stimulation (NuEyne 01) |
| Control Group | Sham comparator | Dry eye disease patients (n=12) Receives: Device: Sham Pulse Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Ocular Surface Disease Index (OSDI) score
Check the changes in Ocular Surface Disease Index (OSDI) score
Measured: baseline, 1, 4, 12 weeks
Changes in Tear break-up time (T-BUT)
Check the changes in Tear break-up time (T-BUT)
Measured: Time Frame: baseline, 1, 4, 12 weeks
Secondary outcomes (9)
Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
Check the changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
Measured: baseline, 1, 4, 12 weeks
Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Check the changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Measured: baseline, 1, 4, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Check the changes in Visual Analogue Scale (VAS) score
Measured: baseline, 1 day, 3 days, 7 days
Changes in Staining Score
Check the changes in Staining Score
Measured: baseline, 1, 4, 12 weeks
Changes in Matrix Metalloproteinase-9 (MMP-9) level
Check the changes in Matrix Metalloproteinase-9 (MMP-9) level
Measured: baseline, 4, 12 weeks
Changes in LipiView Eye Lipid Layer Thickness
Check the changes in LipiView Eye Lipid Layer Thickness
Measured: baseline, 4, 12 weeks
Changes in Tear Volume
Check the changes in Tear Volume
Measured: baseline, 1, 4, 12 weeks
Changes in Tear Osmolarity
Check the changes in Tear Osmolarity
Measured: baseline, 4, 12 weeks
Changes in the length of the aesthesiometer's filament in centimeters
Check the changes in the length of the aesthesiometer's filament in centimeters
Measured: baseline, 1, 4, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start28 Feb 2020
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donghui Lim, Ph. D., MD., Principal investigator, Department of Ophthalmology, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271422
- Sponsor's protocol ID
- NE_DED_001
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05271422
- Acronym / sponsor ID
- NE_DED_001
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2020 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Real Pulse Electrical Stimulation (NuEyne 01)Dry eye disease patients (n=12) |
| Control Group | Sham comparator | Device: Sham Pulse Electrical StimulationDry eye disease patients (n=12) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental Group |
| Sham Pulse Electrical StimulationPatients 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. | Device | Control Group |
Primary outcome
Changes in Ocular Surface Disease Index (OSDI) score
Time frame: 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: Time Frame: baseline, 1, 4, 12 weeks
Check the changes in Tear break-up time (T-BUT)
9 secondary outcomes
Changes in 5-Item Dry Eye Questionnaire (DEQ-5 score)
Time frame: baseline, 1, 4, 12 weeks
Changes in Patient Evaluation of Eye Dryness (SPEED) II questionnaire score
Time frame: baseline, 1, 4, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Time frame: baseline, 1 day, 3 days, 7 days
Changes in Staining Score
Time frame: baseline, 1, 4, 12 weeks
Changes in Matrix Metalloproteinase-9 (MMP-9) level
Time frame: baseline, 4, 12 weeks
Changes in LipiView Eye Lipid Layer Thickness
Time frame: baseline, 4, 12 weeks
Changes in Tear Volume
Time frame: baseline, 1, 4, 12 weeks
Changes in Tear Osmolarity
Time frame: baseline, 4, 12 weeks
Changes in the length of the aesthesiometer's filament in centimeters
Time frame: baseline, 1, 4, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
Related trials for Dry Eye Disease
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donghui Lim, Ph. D., MD. principal investigator
Department of Ophthalmology, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real Pulse Electrical Stimulation (NuEyne 01) in people with Dry Eye Disease, run by Nu Eyne Co., Ltd. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Ocular Surface Disease Index (OSDI) score (time frame: baseline, 1, 4, 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.