An interventional study of The Rexon-Eye, an electrotherapy device utilizing Quantum Molecular Resonance (QMR) technology in Dry Eye Disease (DED) and Dry Eye, sponsored by The Hong Kong Polytechnic University. Completed at 1 site in Hong Kong. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-16.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Diagnostic
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.
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.
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This study's enrollment of 75 is above the median of 60 across 1,077 interventional studies indexed under Dry Eye Syndromes.
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Fail one of the three diagnostic tests:
Exclusion Criteria:
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
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
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
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.
Clinical efficacy
Ocular Surface Disease Index
Time frame: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
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
Time frame: From enrollment to the end of treatment at 4 (Treatment group) to 8 (Sham treatment group)months
Plan to share: No
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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The Hong Kong Polytechnic University