Dry Eye DiseaseNCT06120348
Study of Application of Pulse Electrical Stimulation Around Eye in Dry Eye Disease Patients Who Are Scheduled for Laser Epithelial Keratomileusis (LASEK) Surgery
A study testing Charge-Balanced, Symmetric Nerve Stimulation in people with Dry Eye Disease, run by Nu Eyne Co., Ltd. at 6 sites in South Korea.
Trial summary
This study aims to evaluate the efficacy and safety of applying pulse Electrical Stimulation around eye after laser keratoplasty (LASEK) in patients with dry eye syndrome. 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?
- Charge-Balanced, Symmetric Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- 6 sitesSouth Korea
- Study dates
- 31 Aug 2023to 31 Aug 2024
- 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
- Men and women aged 19 to 60
- Those who are scheduled to get LASEK surgery
- Those who have had dry eye symptoms for more than 3 months.
- According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
- Those who TBUT test results of less than 10 seconds
- Those who OSDI score of 13 or higher
- Those who agreed to use contraception using a medically acceptable method during the period of clinical trial among Women of child bearing potential (WOCBP).
- A person who voluntarily agreed to participate in this clinical trial.
Who cannot join
- A person who has applied cyclosporin for the treatment of dry eye syndrome, drugs such as lipid-containing eye drops, topical steroid eye drops, IPL, etc., and medical devices for the treatment of dry eye syndrome within one month from the screening
- A person with an uncontrollable systemic chronic disease.
- 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, Punctal plug insertion, Pterygium surgery)
- 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
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- A person with abnormalities in the eyelids or eyelashes
- A person with an eye condition or ophthalmic disease that is considered unsuitable for surgery
- A person who takes systemic drugs (e.g., tetracycline derivatives, antihistamine, isotretinoin)
- 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).)
- Those who wore contact lenses within 72 hours before screening or who must wear contact lenses during the clinical trial period
- Those who have taken the relevant systemic drugs (steroids, immunosuppressants, omega-3 and anticholinergic drugs, etc.) within 30 days from the date of screening
- Those who are judged to have problems attaching electrodes due to inflammatory reactions or other dermatological problems in the skin around the orbit where the electrodes of medical devices are attached
- Those who participated in other clinical trial within 30 days from the screening date
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
South Korea6 sites, 6 recruiting
- Recruiting
HanGil Medical Foundation
Incheon, 21388
Sang Mok Lee, Ph. D., MD
- Recruiting
Department of Ophthalmology, Kangbuk Samsung Hospital
Seoul, 03181
Chul Young Choi, Ph. D., MD
- Recruiting
Department of Ophthalmology, Severance Hospital
Seoul, 03722
Tae-im KIM, Ph. D., MD
- Recruiting
Nune Eye Hospital
Seoul, 06192
Kyoung Yoon Shin, Ph. D., MD
- Recruiting
Department of Ophthalmology, Samsung Medical Center
Seoul, 06351
Donghui Lim, Ph. D., MD., +82234103569, donghui.lim@samsung.com
- Recruiting
Kim's Eye Hospital
Seoul, 07301
Kyung min Koh, Ph. D., MD
About this study
Official title: Multi-center, Placebo-controlled, Randomized, Parallel Design, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Application of Electrical Stimulation Around Eye After Laser Keratoplasty (LASEK) in Patients With Dry Eye Syndrome.
This study aims to evaluate the efficacy and safety of applying pulse Electrical Stimulation around eye after laser keratoplasty (LASEK) in patients with dry eye syndrome.
Read the detailed description
Duration of study period (per participant): Screening period (0-4weeks). Intervention period (12weeks).
Patient needs to visit site at least 8 times (Screening, baseline, 1 day, 3day, 1, 4, 8, 12weeks based on baseline). Baseline visit will be done on the day of surgery.
- Conditions
- Dry Eye Disease
- Being tested
- Charge-Balanced, Symmetric Nerve Stimulation, Sham 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.
Charge-Balanced, Symmetric Nerve StimulationDevice
Charge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
Sham StimulationDevice
Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Charge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. Receives: Device: Charge-Balanced, Symmetric Nerve Stimulation |
| Control Group | Sham comparator | Sham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. Receives: Device: Sham Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Tear break-up time (T-BUT)
Check the changes in Tear break-up time (T-BUT)
Measured: baseline, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Check the changes in Visual Analogue Scale (VAS) score
Measured: baseline, 1 week
Secondary outcomes (6)
Changes in Tear break-up time (T-BUT)
Check the changes in Tear break-up time (T-BUT)
Measured: baseline, 1, 4, 8 weeks
Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score
Check the changes in 5-Item Dry Eye Questionnaire Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease (OSDI) score
Measured: baseline, 1, 4, 8, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Check the changes in Visual Analogue Scale (VAS) score
Measured: baseline, 3 days, 4, 8, 12 weeks
Changes in Staining Score
Check the changes in Staining Score
Measured: baseline, 1, 4, 8, 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, 8, 12 weeks
Changes in Tear Volume
Check the changes in Tear Volume
Measured: baseline, 1, 4, 8, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start31 Aug 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Aug 2024 (estimated)
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nu Eyne Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dong Hui Lim, Ph. D., MD, Principal investigator, Department of Ophthalmology, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06120348
- Sponsor's protocol ID
- NE_DED_003
- Status last verified
- Nov 2023
- First submitted
- 2 Nov 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Placebo-controlled, Randomized, Parallel Design, Superiority, Pivotal Clinical Trial to Evaluate the Efficacy and Safety of Application of Electrical Stimulation Around Eye After Laser Keratoplasty (LASEK) in Patients With Dry Eye Syndrome.
- ClinicalTrials.gov ID
- NCT06120348
- Acronym / sponsor ID
- NE_DED_003
- Conditions
- Dry Eye Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Nu Eyne Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 7 Nov 2023 (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 after laser keratoplasty (LASEK) in patients with dry eye syndrome.
Detailed description
Duration of study period (per participant): Screening period (0-4weeks). Intervention period (12weeks).
Patient needs to visit site at least 8 times (Screening, baseline, 1 day, 3day, 1, 4, 8, 12weeks based on baseline). Baseline visit will be done on the day of surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Charge-Balanced, Symmetric Nerve StimulationCharge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. |
| Control Group | Sham comparator | Device: Sham StimulationSham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Men and women aged 19 to 60
- Those who are scheduled to get LASEK surgery
- Those who have had dry eye symptoms for more than 3 months.
- According to the guidelines for diagnosing dry eye syndrome of Korean Corneal Disease Study Group, those who fall under Grade II or higher
- Those who TBUT test results of less than 10 seconds
Key exclusion criteria (16 listed)
- A person who has applied cyclosporin for the treatment of dry eye syndrome, drugs such as lipid-containing eye drops, topical steroid eye drops, IPL, etc., and medical devices for the treatment of dry eye syndrome within one month from the screening
- A person with an uncontrollable systemic chronic disease.
- 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, Punctal plug insertion, Pterygium surgery)
- A person who has eyelid diseases or structural abnormalities
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 |
|---|---|---|
| Charge-Balanced, Symmetric Nerve StimulationCharge-Balanced, Symmetric Nerve Stimulation device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. | Device | Experimental Group |
| Sham StimulationSham device 30 mins once a day for 4weeks(28days) and twice a week from the 5weeks to the 12 weeks. | Device | Control Group |
Primary outcome
Changes in Tear break-up time (T-BUT)
Time frame: baseline, 12 weeks
Check the changes in Tear break-up time (T-BUT)
Changes in Visual Analogue Scale (VAS) score
Time frame: baseline, 1 week
Check the changes in Visual Analogue Scale (VAS) score
6 secondary outcomes
Changes in Tear break-up time (T-BUT)
Time frame: baseline, 1, 4, 8 weeks
Changes in 5-Item Dry Eye Questionnaire (DEQ-5) and Ocular Surface Disease Index (OSDI) score
Time frame: baseline, 1, 4, 8, 12 weeks
Changes in Visual Analogue Scale (VAS) score
Time frame: baseline, 3 days, 4, 8, 12 weeks
Changes in Staining Score
Time frame: baseline, 1, 4, 8, 12 weeks
Changes in the length of the aesthesiometer's filament in centimeters
Time frame: baseline, 1, 4, 8, 12 weeks
Changes in Tear Volume
Time frame: baseline, 1, 4, 8, 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Dong Hui Lim, Ph. D., MD principal investigator
Department of Ophthalmology, Samsung Medical Center
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Charge-Balanced, Symmetric Nerve Stimulation in people with Dry Eye Disease, run by Nu Eyne Co., Ltd. at 6 sites 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 8 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinho Jung, Ph.D Candi. (+821083113509, jinho.jung@nueyne.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Tear break-up time (T-BUT) (time frame: baseline, 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 13 Nov 2023.