Dry Eye Disease (DED)NCT06955806
Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management
A study testing The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology in people with Dry Eye Disease (DED), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This project aims to investigate the clinical efficacy and molecular mechanisms of Quantum Molecular Resonance (QMR) electrotherapy in the management of dry eye disease (DED). DED is a multifactorial condition characterized by tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Dry Eye Disease (DED)
- 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
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 31 May 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- aged 18 to 40 years old
- with habitual or best corrected visual acuity better than or equal to 6/9
- diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.
Who cannot join
- history of ocular inflammation, trauma or surgery within 6 months
- long-term ocular medications
- current dry eye treatment
- uncontrolled, newly diagnosed systemic diseases
- with modified long-term medications within 6 months that are known to affect tear profile
- carrying active implantable devices (e.g., pacemakers and hearing aids)
Trial locations and contacts
1 site in 1 country.
About this study
This project aims to investigate the clinical efficacy and molecular mechanisms of Quantum Molecular Resonance (QMR) electrotherapy in the management of dry eye disease (DED). DED is a multifactorial condition characterized by tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities, leading to discomfort and visual disturbances. The Rexon-Eye device, which utilizes QMR technology, has shown positive effects in alleviating dry eye symptoms. However, the exact mechanisms by which the stimulation of high-frequency electrical fields promotes improvement in DED remain unclear.
The research will be conducted as a longitudinal study involving 30 participants between the ages of 18 and 40 who meet the diagnostic criteria for DED. Participants will be randomly assigned to either a treatment group receiving QMR electrotherapy or a control group receiving a sham treatment, followed by a real treatment after second evaluation. Each participant in the treatment group will undergo a 20-minute weekly session for four weeks, with clinical evaluations and tear fluid collection occurring throughout the study.
Read more
Comprehensive assessments will be performed to evaluate tear film stability, lipid layer composition, ocular surface health and corneal sensitivity. Tear samples collected during the study will undergo molecular analysis using mass spectrometry to identify biochemical changes associated with QMR electrotherapy. Additionally, safety evaluations will be conducted at each visit to monitor potential adverse effects.
The study aims to determine whether QMR electrotherapy effectively improves clinical dry eye parameters while also uncovering the molecular changes in tear composition that may underlie its therapeutic effects. By exploring both clinical outcomes and biological mechanisms, this research will contribute valuable insights into the potential of QMR electrotherapy as an innovative treatment for dry eye disease.
Read the detailed description
Study Purpose and Potential Benefits:
Recently, a high frequency electrotherapy device using Quantum Molecular Resonance (QMR) technique, the Rexon-Eye was being developed for dry eye treatment. During the treatment, a low-intensity, high-frequency (a spectrum of frequencies ranging from 4 MHz to 64 MHz) electrical stimulations are applied on the epidermis of closed eyelids up to the lid border by specially 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. Compared with conventional DED management options such as lubricant and warm compress, previous studies proposed that this treatment may allow a possible capability to induce reactivation of physiological lacrimal functions instead of a short-term symptom relief.
The aims of this project are to investigate the clinical efficacy of QMR electrotherapy and the associated changes in tear proteomics and lipidomics in the management of dry eye disease.
Participant Eligibility
- aged 18 to 40 years old
- with habitual or best corrected visual acuity better than or equal to 6/9
- diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.
Exclusion criteria:
- history of ocular inflammation, trauma or surgery within 6 months
- long-term ocular medications
- current dry eye treatment
- uncontrolled, newly diagnosed systemic diseases
- with modified long-term medications within 6 months that are known to affect tear profile
- carrying active implantable devices (e.g., pacemakers and hearing aids) Contact lens wearers will be required to stop contact lens wear 1 month before the first evaluation and during the whole study period.
Study Procedure All the participants will be given a comprehensive dry eye assessment at the baseline visit (visit1). The assessment includes questionnaire filling, ocular surface checking, tear fluid examination and collection, and eyelid examination.
Participants will then be assigned to receive QMR treatment, which requires four sessions of treatment (on a weekly basis). Two post treatment comprehensive dry eye assessment will be scheduled one month after the 4th treatment, and three months after the 4th treatment.
Some participants may be given another four sessions of treatment (on a weekly basis), followed by two post treatment comprehensive dry eye assessment (also one month after the 4th treatment, and three months after the 4th treatment). In summary, some participants need to visit us 6 times in 5 months while the others may need to visit us 12 times in 8 months.
Parameters to be assessed in Comprehensive evaluation:
- Dry Eye Disease (DED) questionnaires - Ocular Surface Disease Index (OSDI)
- Non-invasive tear break-up time (NITBUT), tear meniscus height (TMH) - Keratograph® 5M
- Lipid layer thickness (LLT) and infrared meibography - idra® Ocular Surface Analyser
- External ocular health, ocular surface staining and lid margin assessment - Slit-lamp biomicroscopy and fluorescein strips
- Corneal sensitivity - Corneal Esthesiometer Brill
Potential Risk(s) or Discomfort(s) and their minimization(s):
EC certificate has certified the device safety of Rexon-Eye including electrical safety and electromagnetic compatibility, and also its clinical safety and effectiveness in treating DED. There is no anticipated risk to participants according to the current literature. All procedures will be conducted by a registered or student optometrist.
Some possible treatment induced effects included a sensation of about 3 to 4°C temperature increment underneath the treatment goggles; transient blurred vision after treatment caused by the pressure of the goggles to the closed eyelid; or transient eyelid skin redness for subjects with sensitive skin. From published results, all these effects should be reversible and disappear within minutes after the treatment is finished. Eye check will be done before and after the treatment to avoid any potential problem.
The treatment will be terminated if the subject is sensitive to the procedure or any unexpected adverse response is observed during the study.
- Conditions
- Dry Eye Disease (DED)
- Being tested
- The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology
- Keywords
- Dry eye
- 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 |
|---|---|---|
| Treatment Arm | Active comparator | Following a comprehensive evaluation, the treatment group 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 |
| 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 and lipidomics changes after Electrotherapy
The associated changes in tear proteomics and lipidomics will be investigated.
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 posted2 May 2025
- Study start31 May 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955806
- Sponsor's protocol ID
- HSEARS20250209003
- Status last verified
- Sep 2025
- First submitted
- 25 Apr 2025
- Last updated
- 12 Sep 2025
- Results posted
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management
- ClinicalTrials.gov ID
- NCT06955806
- Acronym / sponsor ID
- HSEARS20250209003
- Conditions
- Dry Eye Disease (DED)
- Keywords
- Dry eye
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project aims to investigate the clinical efficacy and molecular mechanisms of Quantum Molecular Resonance (QMR) electrotherapy in the management of dry eye disease (DED). DED is a multifactorial condition characterized by tear film instability, hyperosmolarity, inflammation, and neurosensory abnormalities, leading to discomfort and visual disturbances. The Rexon-Eye device, which utilizes QMR technology, has shown positive effects in alleviating dry eye symptoms. However, the exact mechanisms by which the stimulation of high-frequency electrical fields promotes improvement in DED remain unclear.
The research will be conducted as a longitudinal study involving 30 participants between the ages of 18 and 40 who meet the diagnostic criteria for DED. Participants will be randomly assigned to either a treatment group receiving QMR electrotherapy or a control group receiving a sham treatment, followed by a real treatment after second evaluation. Each participant in the treatment group will undergo a 20-minute weekly session for four weeks, with clinical evaluations and tear fluid collection occurring throughout the study.
Comprehensive assessments will be performed to evaluate tear film stability, lipid layer composition, ocular surface health and corneal sensitivity. Tear samples collected during the study will undergo molecular analysis using mass spectrometry to identify biochemical changes associated with QMR electrotherapy. Additionally, safety evaluations will be conducted at each visit to monitor potential adverse effects.
The study aims to determine whether QMR electrotherapy effectively improves clinical dry eye parameters while also uncovering the molecular changes in tear composition that may underlie its therapeutic effects. By exploring both clinical outcomes and biological mechanisms, this research will contribute valuable insights into the potential of QMR electrotherapy as an innovative treatment for dry eye disease.
Detailed description
Study Purpose and Potential Benefits:
Recently, a high frequency electrotherapy device using Quantum Molecular Resonance (QMR) technique, the Rexon-Eye was being developed for dry eye treatment. During the treatment, a low-intensity, high-frequency (a spectrum of frequencies ranging from 4 MHz to 64 MHz) electrical stimulations are applied on the epidermis of closed eyelids up to the lid border by specially 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. Compared with conventional DED management options such as lubricant and warm compress, previous studies proposed that this treatment may allow a possible capability to induce reactivation of physiological lacrimal functions instead of a short-term symptom relief.
The aims of this project are to investigate the clinical efficacy of QMR electrotherapy and the associated changes in tear proteomics and lipidomics in the management of dry eye disease.
Participant Eligibility
- aged 18 to 40 years old
- with habitual or best corrected visual acuity better than or equal to 6/9
- diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.
Exclusion criteria:
- history of ocular inflammation, trauma or surgery within 6 months
- long-term ocular medications
- current dry eye treatment
- uncontrolled, newly diagnosed systemic diseases
- with modified long-term medications within 6 months that are known to affect tear profile
- carrying active implantable devices (e.g., pacemakers and hearing aids) Contact lens wearers will be required to stop contact lens wear 1 month before the first evaluation and during the whole study period.
Study Procedure All the participants will be given a comprehensive dry eye assessment at the baseline visit (visit1). The assessment includes questionnaire filling, ocular surface checking, tear fluid examination and collection, and eyelid examination.
Participants will then be assigned to receive QMR treatment, which requires four sessions of treatment (on a weekly basis). Two post treatment comprehensive dry eye assessment will be scheduled one month after the 4th treatment, and three months after the 4th treatment.
Some participants may be given another four sessions of treatment (on a weekly basis), followed by two post treatment comprehensive dry eye assessment (also one month after the 4th treatment, and three months after the 4th treatment). In summary, some participants need to visit us 6 times in 5 months while the others may need to visit us 12 times in 8 months.
Parameters to be assessed in Comprehensive evaluation:
- Dry Eye Disease (DED) questionnaires - Ocular Surface Disease Index (OSDI)
- Non-invasive tear break-up time (NITBUT), tear meniscus height (TMH) - Keratograph® 5M
- Lipid layer thickness (LLT) and infrared meibography - idra® Ocular Surface Analyser
- External ocular health, ocular surface staining and lid margin assessment - Slit-lamp biomicroscopy and fluorescein strips
- Corneal sensitivity - Corneal Esthesiometer Brill
Potential Risk(s) or Discomfort(s) and their minimization(s):
EC certificate has certified the device safety of Rexon-Eye including electrical safety and electromagnetic compatibility, and also its clinical safety and effectiveness in treating DED. There is no anticipated risk to participants according to the current literature. All procedures will be conducted by a registered or student optometrist.
Some possible treatment induced effects included a sensation of about 3 to 4°C temperature increment underneath the treatment goggles; transient blurred vision after treatment caused by the pressure of the goggles to the closed eyelid; or transient eyelid skin redness for subjects with sensitive skin. From published results, all these effects should be reversible and disappear within minutes after the treatment is finished. Eye check will be done before and after the treatment to avoid any potential problem.
The treatment will be terminated if the subject is sensitive to the procedure or any unexpected adverse response is observed during the study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Active comparator | Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technologyFollowing a comprehensive evaluation, the treatment group will undergo a 20-minute treatment once per week for four weeks. |
| Control Arm | Sham comparator | Device: The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technologyFollowing 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- aged 18 to 40 years old
- with habitual or best corrected visual acuity better than or equal to 6/9
- diagnosed as dry eye disease according to OSDI score (13 or above) and at least one positive result from dry eye assessment.
Key exclusion criteria (6 listed)
- history of ocular inflammation, trauma or surgery within 6 months
- long-term ocular medications
- current dry eye treatment
- uncontrolled, newly diagnosed systemic diseases
- with modified long-term medications within 6 months that are known to affect tear profile
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technologyThe 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. | Device | Control Arm, Treatment Arm |
Primary outcome
clinical efficacy
Time frame: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
Ocular Surface Disease Index
1 secondary outcome
The associated tear proteomics and lipidomics changes after Electrotherapy
Time frame: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Results publication: PubMed 35851496Trivli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology in people with Dry Eye Disease (DED), run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical efficacy (time frame: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06955806, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.