Rexon-Eye in Dry Eye

October 25, 2022 updated by: Louis Tong, Singapore National Eye Centre

Efficacy and Safety of Rexon Eye in Asian Dry Eye

Resono Ophthalmic has developed Rexo-Eye in 2014, a QMR-based patented instrument which is hypothesised to stimulate physiological cellular regeneration and reactivate the tear system by stimulating and reactivating the lacrimal system, induce mild hyperthermia and massage effects which reactivate the tear and lipid secretion, targeting all arms of pathogenic mechanisms of dry eye disease. By improving cell migration and cell health, eye surface epithelial problems in dry eyes which are hard to reverse could hopefully be improved. It has been marked since 2016 as a medical device for the treatment of ocular surface disorders and patented in Italy and Europe, with other international patents pending. In this study, we aim to assess the efficacy and safety of Rexon-Eye in dry eye patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dry eye disease, or ocular surface disease (OSD)as defined by the International Dry Eye Workshop (2007)1, is a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance and tear film instability with potential damage to the ocular surface.1

There is an armantaranium of therapies different types of dry eyes such as lubricating eyedrops, moisture retention chamber, intense pulsed light which are not curative and require repetitive application. Recently, Quantum molecular resonance (QMR) has emerged as a new treatment for all types of dry eyes. This technology involves transpalpebral non-invasive high frequency microcurrent electrical stimulation of cells which stimulate natural regeneration of cells. With the application of low-power high-frequency oscillating electrical currents in the range of 4 to 64 megahertz, it works via the resonance effect by maximising delivery of energy to biological tissues by oscillating electrical fields without increasing temperature and eliciting biological responses.2, 3 A previous in-vitro study had evaluated the biophysical effects these high frequency electrical fields on cells in culture, which showed that it invoked a series of cellular massage of contractions and relaxations' which trigger cellular metabolism and stimulate tissues.

Resono Ophthalmic has developed Rexo-Eye in 2014, a QMR-based patented instrument which is hypothesised to stimulate physiological cellular regeneration and reactivate the tear system by stimulating and reactivating the lacrimal system, induce mild hyperthermia and massage effects which reactivate the tear and lipid secretion, targeting all arms of pathogenic mechanisms of dry eye disease. By improving cell migration and cell health, eye surface epithelial problems in dry eyes which are hard to reverse could hopefully be improved. It has been marked since 2016 as a medical device for the treatment of ocular surface disorders and patented in Italy and Europe, with other international patents pending. Therapy takes place in the form of special mask electrodes applied to the patient's periorbital area worn for 20 minutes per session.

Earlier studies have shown evidence to improve subjective and objective symptoms of dry eye disease as well as to successfully reduce the number of tear substitute eye drops over a 2 month treatment period with Rexon-Eye. However, these studies are mainly small scale and conducted in Western populations. There have been no other studies conducted in Asian populations on the efficacy and safety of the Rexon-Eye device in targeting dry eye disease. Thus our study aims to evaluate these two aims through this study, while determining patient satisfaction and acceptability of the technology and furthermore, exploring changes in the composite of tears before and after the Rexon-Eye device.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 169856
        • Singapore Eye Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 21 years old and above;
  2. Diagnosed with moderate dry eyes based on grade 3 and worse corneal fluorescein staining in the central interpalpebral region
  3. Are on other eye drops (including artificial tears, topical ciclosporin, steroids), blephagel or lid warming solely for dry eyes, with no recent change in the last 1 month;
  4. Willing to perform all eye examinations in this study;
  5. Clear of exclusion criteria

Exclusion Criteria:

  1. Pregnant women
  2. Patients carrying active implantable device (e.g., pacemakers and hearing aids)
  3. Oncologic patients under treatment
  4. Patient who underwent ocular surgery in the last month
  5. Patients who are vegan or exclude egg in their diet
  6. Patient who is on antibiotic or glaucoma eye drops
  7. Patient who had ocular infection within 6 months
  8. Any other specified reason as determined by clinical investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Full power treatment 4
These group of participants will receive the full power treatment 4
This treatment involved the technology known as quantum molecular resonance (QMR) which has emerged as a new treatment for all types of dry eyes.
Placebo Comparator: Comparative Power 1
These group of participants will receive the comparative power 1 treatment
This treatment involved the technology known as quantum molecular resonance (QMR) which has emerged as a new treatment for all types of dry eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SPEED Questionnaire to access the dry eye symptoms
Time Frame: 3 months
To assess the improvement of dry eye symptoms by SPEED questionnaire
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptance of treatment (Rexon-eye)
Time Frame: 3 months
Participants will be asked to answer some questions on the satisfaction and acceptability of Rexon-eye treatment
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Louis Tong, PhD, Singapore Eye Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2019

Primary Completion (Actual)

August 30, 2022

Study Completion (Actual)

August 30, 2022

Study Registration Dates

First Submitted

March 19, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (Actual)

March 25, 2020

Study Record Updates

Last Update Posted (Actual)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R1624/21/2019
  • 2019/2446 (Registry Identifier: SingHealth CIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dry Eye

Clinical Trials on Rexon-eye

3
Subscribe