Rexon-Eye in Dry Eye

NCT04320563 | Completed

• 2 other identifiers: R1624/21/20192019/2446
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye

Keywords

Rexon-eye

Outcome Measures

Primary Outcomes (1)

• SPEED Questionnaire to access the dry eye symptoms

  To assess the improvement of dry eye symptoms by SPEED questionnaire

  3 months

Secondary Outcomes (1)

• Acceptance of treatment (Rexon-eye)

  3 months

Study Arms (2)

Full power treatment 4

ACTIVE COMPARATOR

These group of participants will receive the full power treatment 4

Procedure: Rexon-eye

Comparative Power 1

PLACEBO COMPARATOR

These group of participants will receive the comparative power 1 treatment

Procedure: Rexon-eye

Interventions

Rexon-eye PROCEDURE

This treatment involved the technology known as quantum molecular resonance (QMR) which has emerged as a new treatment for all types of dry eyes.

Comparative Power 1; Full power treatment 4

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore National Eye Centre: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Louis Tong, PhD

  Singapore Eye Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both the participants and Investigators were masked. Only the study staff we helped with the Rexon-eye treatment was unmasked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician-Scientist, Senior Consultant

Study Record Dates

• First Submitted: March 19, 2020
• First Posted: March 25, 2020
• Study Start: July 20, 2019
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)