iTear Single-center, Open-label, Single-arm Study

Launched by THE UNIVERSITY OF HONG KONG · Jul 23, 2024

Keywords

ClinConnect Summary

The iTear study is looking at a new device called the iTEAR100 Neurostimulator, which is designed to help people suffering from Dry Eye Disease (DED) who aren't finding relief with artificial tears. Over three months, thirty participants will use this device, which works by stimulating the outside of the nose to improve their dry eye symptoms. Participants will visit the clinic three times: at the start of the study, after 30 days, and at the end of the study. They will use the device twice a day for the first month and then as needed for the next two months. The researchers will measure how much the participants' symptoms improve and will keep track of any side effects.

To be eligible for the study, you need to be between 65 and 74 years old and have been using artificial tears for your dry eyes within the last month. You should also have a specific level of dry eye symptoms and test results that show your eyes are not producing enough tears. However, if you have used similar devices recently or are involved in other clinical trials, you won't be able to participate. This study aims to find a new way to help people with persistent dry eye issues, hopefully leading to better treatments in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Each patient must meet all the following criteria to be enrolled in this study:
• • 1. Provided informed consent, approved by the Institutional Review Board (IRB), to participate in the study.
• • 2. Reported use of artificial tears for DED within 30 days of Visit 1.
• • 3. Ocular Surface Disease Index (OSDI) ≥ 23 (with no more than 3 N/A in the answers).
• • 4. Anesthetized Schirmer Test Score ≤ 10 mm/5 min in at least one eye.
• Exclusion Criteria:
• Patients who meet any of the following criteria will be excluded from the study:
• • 1. Used extranasal or intranasal neurostimulator within 30 days of Visit 1.
• • 2. Participation in any clinical trial with an investigational drug or device within 30 days of Visit 1.
• • 3. 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.