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Rexon-Eye in Dry Eye

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ClinicalTrials.gov Identifier: NCT04320563
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : March 25, 2020
Sponsor:
Information provided by (Responsible Party):
Louis Tong, Singapore National Eye Centre

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.

Condition or disease Intervention/treatment Phase
Dry Eye Procedure: Rexon-eye Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Both the participants and Investigators were masked. Only the study staff we helped with the Rexon-eye treatment was unmasked.
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Rexon Eye in Asian Dry Eye
Actual Study Start Date : July 20, 2019
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Arm Intervention/treatment
Active Comparator: Full power treatment 4
These group of participants will receive the full power treatment 4
Procedure: Rexon-eye
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
Procedure: Rexon-eye
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 Measures :
  1. SPEED Questionnaire to access the dry eye symptoms [ Time Frame: 3 months ]
    To assess the improvement of dry eye symptoms by SPEED questionnaire


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04320563


Contacts
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Contact: Louis Tong, PhD 65767200 louis.tong.h.t@singhealth.com.sg
Contact: Cynthia Boo, BsC cynthia.boo.s.k@seri.com.sg

Locations
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Singapore
Singapore Eye Research Institute Recruiting
Singapore, Singapore, 169856
Contact: Cynthia Boo, BsC         
Principal Investigator: Louis Tong, PhD         
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
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Principal Investigator: Louis Tong, PhD Singapore Eye Research Institute
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Responsible Party: Louis Tong, Clinician-Scientist, Senior Consultant, Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT04320563    
Other Study ID Numbers: R1624/21/2019
2019/2446 ( Registry Identifier: SingHealth CIRB )
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Louis Tong, Singapore National Eye Centre:
Rexon-eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases