Rexon-Eye in Dry Eye
Primary Purpose
Dry Eye
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Rexon-eye
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye focused on measuring Rexon-eye
Eligibility Criteria
Inclusion Criteria:
- 21 years old and above;
- Diagnosed with moderate dry eyes based on grade 3 and worse corneal fluorescein staining in the central interpalpebral region
- 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;
- Willing to perform all eye examinations in this study;
- Clear of exclusion criteria
Exclusion Criteria:
- Pregnant women
- Patients carrying active implantable device (e.g., pacemakers and hearing aids)
- Oncologic patients under treatment
- Patient who underwent ocular surgery in the last month
- Patients who are vegan or exclude egg in their diet
- Patient who is on antibiotic or glaucoma eye drops
- Patient who had ocular infection within 6 months
- Any other specified reason as determined by clinical investigator
Sites / Locations
- Singapore Eye Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Full power treatment 4
Comparative Power 1
Arm Description
These group of participants will receive the full power treatment 4
These group of participants will receive the comparative power 1 treatment
Outcomes
Primary Outcome Measures
SPEED Questionnaire to access the dry eye symptoms
To assess the improvement of dry eye symptoms by SPEED questionnaire
Secondary Outcome Measures
Acceptance of treatment (Rexon-eye)
Participants will be asked to answer some questions on the satisfaction and acceptability of Rexon-eye treatment
Full Information
NCT ID
NCT04320563
First Posted
March 19, 2020
Last Updated
October 25, 2022
Sponsor
Singapore National Eye Centre
1. Study Identification
Unique Protocol Identification Number
NCT04320563
Brief Title
Rexon-Eye in Dry Eye
Official Title
Efficacy and Safety of Rexon Eye in Asian Dry Eye
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 20, 2019 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
August 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singapore National Eye Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye
Keywords
Rexon-eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Both the participants and Investigators were masked. Only the study staff we helped with the Rexon-eye treatment was unmasked.
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Full power treatment 4
Arm Type
Active Comparator
Arm Description
These group of participants will receive the full power treatment 4
Arm Title
Comparative Power 1
Arm Type
Placebo Comparator
Arm Description
These group of participants will receive the comparative power 1 treatment
Intervention Type
Procedure
Intervention Name(s)
Rexon-eye
Intervention Description
This treatment involved the technology known as quantum molecular resonance (QMR) which has emerged as a new treatment for all types of dry eyes.
Primary Outcome Measure Information:
Title
SPEED Questionnaire to access the dry eye symptoms
Description
To assess the improvement of dry eye symptoms by SPEED questionnaire
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Acceptance of treatment (Rexon-eye)
Description
Participants will be asked to answer some questions on the satisfaction and acceptability of Rexon-eye treatment
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
21 years old and above;
Diagnosed with moderate dry eyes based on grade 3 and worse corneal fluorescein staining in the central interpalpebral region
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;
Willing to perform all eye examinations in this study;
Clear of exclusion criteria
Exclusion Criteria:
Pregnant women
Patients carrying active implantable device (e.g., pacemakers and hearing aids)
Oncologic patients under treatment
Patient who underwent ocular surgery in the last month
Patients who are vegan or exclude egg in their diet
Patient who is on antibiotic or glaucoma eye drops
Patient who had ocular infection within 6 months
Any other specified reason as determined by clinical investigator
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louis Tong, PhD
Organizational Affiliation
Singapore Eye Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
169856
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
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Rexon-Eye in Dry Eye
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