Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease

NCT07175909 | Recruiting

• 1 other identifier: HSEARS20210311002
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 associated global tear proteome changes, will be investigated.

Conditions

Dry Eye Disease (DED); Dry Eye

Outcome Measures

Primary Outcomes (1)

• Clinical efficacy

  Ocular Surface Disease Index

  From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months

Secondary Outcomes (1)

• The associated tear proteomics changes after treatment

  From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months

Study Arms (3)

DED Treatment Arm

ACTIVE COMPARATOR

Following a comprehensive evaluation,this group of subjects will undergo a 20-minute treatment once per week for four weeks.

Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology

Non- DED Control Arm

OTHER

Following a comprehensive evaluation, this group of subjects will undergo a 20-minute treatment once per week for four weeks.

Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology

DED Control Arm

SHAM COMPARATOR

Following a comprehensive evaluation, the sham treatment group will firstly undergo a 20-minute sham treatment once per week for four weeks. Two additional comprehensive evaluations and tear fluid collections will be conducted one month and three months after the completion of the treatment period. After the three-month post-treatment evaluation, the control group will receive four weekly treatments.

Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology

Interventions

The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology DEVICE

The device has received EC certification as a medical device for the treatment of ocular surface disorders. It will deliver a low-intensity alternating electrical current (ranging from 4 MHz to 64 MHz) to targeted biological tissue via contact electrodes. Previous studies have shown the effectiveness of this treatment in alleviating dry eye symptoms, both subjectively and objectively.

DED Control Arm; DED Treatment Arm; Non- DED Control Arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University, Hong Kong,

Hong Kong, Hong Kong

RECRUITING

Related Publications (1)

• Trivli A, Karmiris E, Dalianis G, Ruggeri A, Terzidou C. Evaluating the efficacy of Quantum Molecular Resonance (QMR) electrotherapy in mixed-type dry eye patients. J Optom. 2023 Apr-Jun;16(2):128-134. doi: 10.1016/j.optom.2022.06.003. Epub 2022 Jul 16.

  PMID: 35851496 BACKGROUND

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Sung Hei Jimmy Tse

  The Hong Kong Polytechnic University, Hong Kong,

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sung Hei Jimmy Tse

CONTACT

852-27664552; jimmy.sh.tse@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Practice

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 16, 2025
• Study Start: January 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)