Status:
NOT_YET_RECRUITING
iTear Single-center, Open-label, Single-arm Study
Lead Sponsor:
The University of Hong Kong
Collaborating Sponsors:
ARCTIC VISION HONG KONG BIOTECH LIMITED
Conditions:
Dry Eye Disease
Dry Eye Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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 usin...
Detailed Description
This is a Phase IV, single-centre, open-label, single-arm study to evaluate the effectiveness and safety of extra nasal neurostimulation in relieving symptoms of patients with Dry Eye Disease (DED) wh...
Eligibility Criteria
Inclusion
- Each patient must meet all the following criteria to be enrolled in this study:
- 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.
Exclusion
- Patients who meet any of the following criteria will be excluded from the study:
- 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.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06525961
Start Date
August 1 2024
End Date
January 1 2026
Last Update
July 29 2024
Active Locations (1)
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1
Department of Ophthalmology, LKS Faculty of Medicine, The University of Hong Kong
Hong Kong, Hong Kong