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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | baseline, 2, 4 weeks |
| Changes in A Five-item Dry Eye Questionnaire(DEQ-5) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Donghui Lim, Ph. D., MD. | donghui.lim@samsung.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology, Samsung Medical Center | Seoul | 06351 | South Korea |
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| 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. |
|
Check the change of A Five-item Dry Eye Questionnaire(DEQ-5) score in the baseline, 2, 4 weeks |
| baseline, 2, 4 weeks |
| Changes in Visual Analog Scale(VAS) score | Check the change of Visual Analog Scale(VAS) score in the baseline, 2, 4 weeks | baseline, 2, 4 weeks |
| Changes in Matrix Metalloproteinases-9(MMP-9) level | Check the change of Matrix Metalloproteinases-9(MMP-9) level in the baseline, 2, 4 weeks | baseline, 2, 4 weeks |
| 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 | baseline, 2, 4 weeks |
| 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 | baseline, 2, 4 weeks |
| Changes in Tear Osmolarity | Check the change of Tear Osmolarity in the baseline, 2, 4 weeks | baseline, 2, 4 weeks |
| Changes in Corneal Sensitivity as measured by aesthesiometer | Check the change of Corneal Sensitivity as measured by aesthesiometer in the baseline, 2, 4 weeks | baseline, 2, 4 weeks |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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