About this trial
This study aims to evaluate the effectiveness and safety of a device, iTEAR100 Neurostimulator (the device), which is designed to help people with Dry Eye Disease (DED) who are not satisfied with using artificial tears. The study will last three months and take place at one location. Thirty participants will use the iTEAR100 Neurostimulator, which stimulates the outside of the nose to help with dry eye symptoms.
Participants will have three main visits: one at the start (Day 0), one after 30 days (Day 30), and one at the end of the study (Day 90). For the first 30 days, they will use the device twice a day for 30 seconds on each side of the nose. After that, they will use it as needed for the next 60 days.
Before starting the treatment, participants will undergo tests to measure their initial eye condition. The effectiveness of the device will be checked by comparing these baseline measurements to those taken on Day 30 and Day 90. Participants will also fill out a questionnaire about their eye symptoms on Day 14.
The main measure of success is how much the participants' symptoms improve on the Ocular Surface Disease Index (OSDI) from Day 0 to Day 30. Other measures include changes in tear production, tear quality, and eye health from Day 0 to Days 30 and 90. Participants' safety will be monitored by tracking any adverse events (side effects) throughout the study.
Eligibility criteria
Qualifiers
Provided informed consent, approved by the Institutional Review Board (IRB), to participate in the study.
Reported use of artificial tears for DED within 30 days of Visit 1.
Ocular Surface Disease Index (OSDI) ≥ 23 (with no more than 3 N/A in the answers).
Anesthetized Schirmer Test Score ≤ 10 mm/5 min in at least one eye.
Disqualifiers
Used extranasal or intranasal neurostimulator within 30 days of Visit 1.
Participation in any clinical trial with an investigational drug or device within 30 days of Visit 1.
In the opinion of the investigator, any condition that could impair study participation/ocular evaluation or the potential risks of participation outweigh the potential benefits.
Trial design
Treatments tested in this trial
- iTEAR100 Neurostimulator
Treatment groups
Sponsors and collaborators
The University of Hong Kong
Lead sponsor
ARCTIC VISION HONG KONG BIOTECH LIMITED
Collaborator