Dry Eye Disease (DED)NCT07175909
Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease
A study testing The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology in people with Dry Eye Disease (DED) and Dry Eye, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Dry Eye Disease (DED), Dry Eye
- What is being tested?
- The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2021to 31 Dec 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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. However, many of these clinical procedures show weak correlation between the clinical findings and subjective symptoms. Therefore, a more reliable method to aid in the diagnosis and management of dry eye disease is clearly needed.
Recently, a high frequency electrotherapy device using Quantum Molecular Resonance (QMR) technique, the Rexon-Eye was approved with EC certificate as a medical device for the treatment of the ocular surface disorders. During the treatment, a low-intensity, high-frequency (a spectrum of frequencies ranging from 4 MHz to 64 MHz) stimulations are applied on the epidermis of closed eyelids up to the lid border by special designed goggles. Previous data showed that it could effectively improve symptoms and clinical signs of DED by increasing the tear secretion and improving the meibomian gland function. Although clinically safe and effective, the mechanisms on how the stimulation could benefit DED are still unknown and ocular changes in response to the DED treatment in molecular level has not yet been investigated.
In this study, the initial tear proteome profiles in DED patients, the safety and effectiveness of using QMR in DED management together with the associated global tear proteome changes will be investigated. A total of 75 participants aged 18 to 65 years old will be recruited. 50 patients are DED patients and will be randomly assigned into treatment group and blinded control group. 25 non-DED age-matched subjects will be recruited as normal control. After the baseline DED evaluation, those eligible patients will be randomly allocated into treatment group and blinded control group. A total of four treatments will be performed to the treatment group and normal control in a weekly bases according the suggested protocol by the manufacturer. The blinded control group will receive sham treatments also in a weekly bases. Two outcome evaluation visits will be arranged for all participants one month and three months after the final treatment (i.e. the 4th treatment). The blinded control group will receive four QMR treatment after the second outcome evaluation visit. The same four treatments (identical to the treatment group) will be conducted followed by two extra outcome evaluation visits. Baseline and post-treatment tears will be collected using Schirmer strips, and changes in the tear proteome will be quantified using a mass spectrometer.
- Conditions
- Dry Eye Disease (DED), Dry Eye
- Being tested
- The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technologyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical efficacy
Ocular Surface Disease Index
Measured: 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
Differences in tear protein groups induced by the treatment, along with their corresponding flow change relative to baseline will be investigated through mass spectrometry analysis
Measured: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jan 2021
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TSE Sung Hei Jimmy, The Hong Kong Polytechnic University
- Investigators
- Sung Hei Jimmy Tse, Principal investigator, The Hong Kong Polytechnic University, Hong Kong,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175909
- Sponsor's protocol ID
- HSEARS20210311002
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35851496