iTear Single-center, Open-label, Single-arm Study
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe University of Hong Kong
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
This trial accepts healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
iTEAR100 Neurostimulator
DeviceTo apply an iTEAR100 Neurostimulator for the stimulation to the anterior ethmoidal nerve - which is located at the point between bony and fleshy tissue alongside the nose. Participants should apply stimulation to each side of the nose for 30 seconds, twice a day. It is recommended to apply once in the morning and once in the evening.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Participants with iTEAR100 NeurostimulatorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
OSDI Score
Change in OSDI at Day 30 from Baseline (Statistical testing using one-sided one-sample t-test)
Time frame
30 Days from baselineSecondary outcomes
1
OSDI Score
1\. Change in OSDI from baseline to Day 14 and Day 90
Time frame
Day 14 and Day 90 from baseline2
Schirmer Test
2\. Change in Schirmer Test Score from baseline to Day 30 and Day 90
Time frame
Day 30 and Day 90 from baseline3
Lipid Layer Thickness (Pre)
3\. Change in tear lipid layer thickness (pre-stimulation) from baseline to Day 30 and Day 90
Time frame
Day 30 and Day 90 from baseline4
Lipid Layer Thickness (Pre vs Post)
4\. Change between pre-stimulation and post-stimulation of tear lipid layer thickness in each visit
Time frame
Day 14, Day 30, Day 90Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Hong Kong
Lead sponsor
ARCTIC VISION HONG KONG BIOTECH LIMITED
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: