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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
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.
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.
Department of Ophthalmology, Samsung Medical Center
Seoul, South Korea
Changes in Tear Break-Up Time(TBUT)
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Changes in Corneal & Conjunctival Fluorescein staining score
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Changes in Ocular Surface Disease Index Dry Eye Questionnaires(OSDI) score
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Changes in A Five-item Dry Eye Questionnaire(DEQ-5) score
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Changes in Visual Analog Scale(VAS) score
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Changes in Matrix Metalloproteinases-9(MMP-9) level
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Changes in Tear Lipid Layer Thickness as measured by Lipiview
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Changes in Tear Volume as measured by Schirmer's Test
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Changes in Tear Osmolarity
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Changes in Corneal Sensitivity as measured by aesthesiometer
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