Status:
RECRUITING
Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease
Lead Sponsor:
The Hong Kong Polytechnic University
Conditions:
Dry Eye Disease (DED)
Dry Eye
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
In this study, the initial tear proteome profiles in Dry Eye Disease (DED) patients, the safety and effectiveness of using an EC certificate DED treatment device in DED management, together with the a...
Detailed Description
Diagnosis of Dry Eye Disease (DED) is current based on questionnaires, quantitative and qualitive tear and ocular surface assessment such as tear breakup time, corneal staining, and tear osmolarity. H...
Eligibility Criteria
Inclusion
- OSDI score ≥ 13, and
- Fail one of the three diagnostic tests:
- Non-invasive tear break-up time (NITBUT) less than 10s;
- Tears osmolarity higher than or equals to 308 mOsm/L or inter-ocular difference \> 8 mOsm/L;
- When assessing with slit lamp, shows more than 9 spots of conjunctival stain with lissamine green, more than 5 spots of corneal stain with fluorescein or lid wiper epitheliopathy (LWE) with lissamine green ≥ 2 mm in length and/or ≥ 25% sagittal width.
Exclusion
- Any active ocular infections, inflammations or anomalies in eyelid;
- Pregnant or lactating;
- Uncontrolled, newly diagnosed systemic diseases or with modified long-term medications within 6 months;
- Carrying active implantable devices (e.g., pacemakers and hearing aids)
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT07175909
Start Date
January 1 2021
End Date
December 31 2025
Last Update
September 16 2025
Active Locations (1)
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1
The Hong Kong Polytechnic University, Hong Kong,
Hong Kong, Hong Kong