The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effective… (NCT05203796) | Clinical Trial Compass
CompletedNot Applicable
The Evaluation of the Transcutaneous Electrical Stimulation Medical Device's Safety and Effectiveness in Treating the Patients With Dry Eye Disease
South Korea24 participantsStarted 2021-08-23
Plain-language 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.
Who can participate
Age range19 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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 bl…
What they're measuring
1
Changes in Tear Break-Up Time(TBUT)
Timeframe: baseline, 2, 4 weeks
2
Changes in Corneal & Conjunctival Fluorescein staining score