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 range
19 Years – 70 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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