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Dry Eye DiseaseNCT05203796

The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Dry Eye Disease

A study testing Transcutaneous pulsed electrical stimulation (NuEyne 02) in people with Dry Eye Disease, run by Nu Eyne Co., Ltd. at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to investigate the safety and effectiveness for applying the electrical stimulation transcutaneously around the eyes and peripheral nerves nearby. The outcomes are compared between the patients with mild- or moderate-level dry eye disease using the real electrical stimulator and the sham… Read more about this study

Who is it for?
Ages 19 to 70 years
Conditions the study is for
Dry Eye Disease
What is being tested?
Transcutaneous pulsed electrical stimulation (NuEyne 02)
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
23 Aug 2021to 26 Jan 2022
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women aged 19 to 70 years old
  • Those who are diagnosed with dry eyes at the time of screening and have complained of dry eyes, discomfort, foreign body sensation, pain, and changes in vision for more than three months.
  • Patients with OSDI score of 23 or more
  • Patients with Fluorescein corneal staining score of 4 or more
  • Schirmer test I result is less than 10mm for 5 minutes
  • TBUT (Tear film break up time) test result of less than 10 seconds
  • Those who agree not to use eye drops other than artificial tears provided in this clinical trial during the clinical trial period
  • A person who voluntarily agreed to participate in this clinical trial

Who cannot join

  • Those who participated in other clinical trials within 30 days of screening.
  • Those who applied medical devices to treat dry eye syndrome and IPL medication such as cyclosporin for treatment of dry eye syndrome and local steroid eye drops within one month from the screening date.
  • Those who have worn contact lenses within 72 hours prior to screening or need to wear contact lenses during the clinical trial period
  • Patients with a history of ophthalmic surgery within 3 months before screening.
  • Those with a history of vision correction surgery (LASIK, LASEK), etc. within 6 months from the screening date
  • Patients who received a lacrimal punctual occlusion or a tear point cauterization of the within 90 days of screening.
Show all 23Show fewer
  • Patients with symptoms of anterior uveitis or active blepharitis.
  • Patients currently receiving treatment for allergic eye disease
  • Patients with an abnormality of the eyelid structure
  • Patients with moderate to severe meibomian gland disorders
  • Those with underlying diseases such as glaucoma, burns, Steven Johnson Syndrome, vitamin A deficiency-related diseases, thyroid dysfunction-related diseases, and neurotropic keratinis.
  • Other clinically significant ophthalmic diseases that are not caused by dry eye disease After corneal transplant surgery, corneal surface disease, abnormal corneal sensitivity, abnormal tear excess, etc. may confuse the interpretation of clinical trial results.
  • Patients with uncontrolled systemic chronic diseases such as diabetes) or a history of malignant tumors
  • Autoimmune disease patients
  • People taking medications such as Steroids, immunosuppressants, omega 3 and anticholinergic drugs, etc.
  • Pregnant or lactating women
  • Among female subjects of childbearing potential, those who do not consent to contraception by a medically accepted method during this clinical trial period
  • Medically permitted contraceptive methods: condoms, oral contraceptives that last at least three months, injections or insertion contraceptives, and installation of intrauterine contraceptives, etc.
  • Patients with a history of drug or alcohol abuse
  • People who are allergic to medicines such as Fluorescein Solution or eye drop anesthetics
  • A person who is judged to have a problem in electrode attachment due to an inflammatory reaction or other dermatological problems in the periorbital skin where the electrode of the medical device for clinical trial is attached
  • A person who is judged to have other reasons for prohibiting the use of medical devices for clinical trials
  • 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 out clinical trial device or is prohibited from using it.)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Department of Ophthalmology, Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

About this study

Official title: A Single-centered, Double-blinded, Placebo/Sham-controlled, Randomized Exploratory Clinical Trial to Evaluate the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Mild- or Moderate-level Dry Eye Disease Using NuEyne 02 (Personal Stimulator)

The purpose of this study is to investigate the safety and effectiveness for applying the electrical stimulation transcutaneously around the eyes and peripheral nerves nearby. The outcomes are compared between the patients with mild- or moderate-level dry eye disease using the real electrical stimulator and the sham electrical stimulator.

Read the detailed description

Duration of study period(per participant): Screening period (0-4weeks), Intervention period (5weeks).

Patient needs to visit site at least 3 times (Screening, V4, V6), V2 can be done with screening visit.

The clinical trial device performs a personal electrical stimulator around the eyes and peripheral nerves for 28 days (7 times/week, 30 minutes each time).

During the study period, dry eye examination and treatment methods (only eye drops provided in clinical trials are applied) are carried out in the same way.

Conditions
Dry Eye Disease
Being tested
Transcutaneous pulsed electrical stimulation (NuEyne 02), 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.

  • Transcutaneous pulsed electrical stimulation (NuEyne 02)Device

    Arm 1: Experimental: Experimental group: Dry eye disease patients (n=12) Device: Pulse Electrical Stimulation Pulse Electrical Stimulation: Patients wear our clinical trial device 30mins once a day for 4 weeks.

  • Sham stimulationDevice

    Arm 2: Sham Comparator: Comparison group: Dry eye disease patients (n=12) Device: Sham stimulation Sham stimulation: Patients wear our clinical trial device 30mins once a day for 4 weeks.

Study groups in NCT05203796
Study groupRoleWhat they receive
Experimental group: Dry eye disease patients (n=12)ExperimentalPatient needs to visit site at least 7 times(Screening, Baseline, wk1, wk2, wk3, wk4, wk5). From baseline visit, patients wear our clinical trial device 30mins per day for 5wks(2Hz stimulation). All other procedures during clinical trial the are the same. Intervention: Device: Transcutaneous pulsed electrical stimulation
Receives: Device: Transcutaneous pulsed electrical stimulation (NuEyne 02)
Comparison group: Dry eye disease patients (n=12)Sham comparatorPatient needs to visit site at least 7 times(Screening, Baseline, wk1, wk2, wk3, wk4, wk5). From baseline visit, patients wear our clinical trial device 30mins per day for 5wks(sham stimulation). All other procedures during clinical trial the are the same. Intervention: Device: Sham device
Receives: Device: Sham stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in Tear Break-Up Time(TBUT)

    Check the change of Tear Break-Up Time(TBUT) in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  2. Changes in Corneal & Conjunctival Fluorescein staining score

    Check the change of Corneal \& Conjunctival Fluorescein staining score in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

Secondary outcomes (8)

  1. Changes in Ocular Surface Disease Index Dry Eye Questionnaires(OSDI) score

    Check the change of Ocular Surface Disease Index Dry Eye Questionnaires(OSDI) score in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  2. Changes in A Five-item Dry Eye Questionnaire(DEQ-5) score

    Check the change of A Five-item Dry Eye Questionnaire(DEQ-5) score in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  3. Changes in Visual Analog Scale(VAS) score

    Check the change of Visual Analog Scale(VAS) score in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  4. Changes in Matrix Metalloproteinases-9(MMP-9) level

    Check the change of Matrix Metalloproteinases-9(MMP-9) level in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  5. Changes in Tear Lipid Layer Thickness as measured by Lipiview

    Check the change of Tear Lipid Layer Thickness as measured by Lipiview in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  6. Changes in Tear Volume as measured by Schirmer's Test

    Check the change of Tear Volume as measured by Schirmer's Test in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  7. Changes in Tear Osmolarity

    Check the change of Tear Osmolarity in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

  8. Changes in Corneal Sensitivity as measured by aesthesiometer

    Check the change of Corneal Sensitivity as measured by aesthesiometer in the baseline, 2, 4 weeks

    Measured: baseline, 2, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jan 2022
  2. Study start23 Aug 2021
  3. Primary completion26 Jan 2022
  4. Study completion26 Jan 2022

Resources

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)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05203796
Sponsor's protocol ID
NE_DED_002
Status last verified
Jan 2022
First submitted
16 Dec 2021
Last updated
9 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Transcutaneous pulsed electrical stimulation (NuEyne 02) 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 8 inclusion and 23 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 Feb 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 Tear Break-Up Time(TBUT) (time frame: baseline, 2, 4 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?

On the ClinicalTrials.gov record for NCT05203796.

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 Feb 2022.

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