Tear protein patterns and gentle eyelid electrotherapy for diagnosing and treating dry eye disease
Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease
This test will see if analyzing proteins in tears and using a gentle eyelid electrotherapy device can improve diagnosis and symptoms for adults with dry eye.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Hong Kong Polytechnic University Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT07175909 on ClinicalTrials.gov |
What this trial studies
Current dry eye diagnosis relies on questionnaires and clinical tests that often do not match patients' symptoms, so this project combines molecular and clinical approaches. Researchers will profile the global protein makeup of tears from participants and apply a low‑intensity Quantum Molecular Resonance (QMR) eyelid electrotherapy device (Rexon‑Eye) to study safety, symptom change, and tear proteome shifts. Clinical measures such as OSDI, noninvasive tear breakup time, tear osmolarity, and corneal/conjunctival staining will be collected alongside tear samples before and after treatment. The study plans to enroll about 75 adult participants at The Hong Kong Polytechnic University and follow them with in‑person visits for device sessions and sample collection.
Who should consider this trial
Good fit: Adults with dry eye symptoms (OSDI ≥ 13) who also fail at least one objective test such as NITBUT < 10 s, tear osmolarity ≥ 308 mOsm/L or interocular difference > 8 mOsm/L, or clinically significant corneal/conjunctival staining or lid wiper epitheliopathy.
Not a fit: People with active ocular infections or inflammations, implantable electronic devices (e.g., pacemaker), pregnant or breastfeeding individuals, or those with uncontrolled systemic disease are excluded and unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, the project could lead to more objective tear‑protein based tools to help diagnose dry eye and show whether QMR eyelid therapy can reliably improve symptoms.
How similar studies have performed: Previous clinical reports of the Rexon‑Eye QMR device have shown symptomatic and clinical sign improvements, but its effects on the tear proteome and the molecular mechanisms remain untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where this trial is running
Hong Kong
- The Hong Kong Polytechnic University, Hong Kong, — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Sung Hei Jimmy Tse — The Hong Kong Polytechnic University, Hong Kong,
- Study coordinator: Sung Hei Jimmy Tse
- Email: jimmy.sh.tse@polyu.edu.hk
- Phone: 852-27664552
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.