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

NCT05203796 | Completed

• 1 other identifier: NE_DED_002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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 electrical stimulator.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• Changes in Tear Break-Up Time(TBUT)

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

  baseline, 2, 4 weeks

• Changes in Corneal & Conjunctival Fluorescein staining score

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

  baseline, 2, 4 weeks

Secondary Outcomes (8)

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

  baseline, 2, 4 weeks

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

  baseline, 2, 4 weeks

• Changes in Visual Analog Scale(VAS) score

  baseline, 2, 4 weeks

• Changes in Matrix Metalloproteinases-9(MMP-9) level

  baseline, 2, 4 weeks

• Changes in Tear Lipid Layer Thickness as measured by Lipiview

  baseline, 2, 4 weeks

Study Arms (2)

Experimental group: Dry eye disease patients (n=12)

EXPERIMENTAL

Patient 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

Device: Transcutaneous pulsed electrical stimulation (NuEyne 02)

Comparison group: Dry eye disease patients (n=12)

SHAM COMPARATOR

Patient 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

Device: Sham stimulation

Interventions

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.

Experimental group: Dry eye disease patients (n=12)

Sham stimulation DEVICE

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.

Comparison group: Dry eye disease patients (n=12)

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Nu Eyne Co., Ltd.: lead

Study Sites (1)

Department of Ophthalmology, Samsung Medical Center

Seoul, 06351, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Donghui Lim, Ph. D., MD.

  donghui.lim@samsung.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 24, 2022
• Study Start: August 23, 2021
• Primary Completion: January 26, 2022
• Study Completion: January 26, 2022
• Last Updated: February 9, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)