Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-14

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The Rexon Eye device (Resono Ophthalmic Inc, Trieste, Italy) is a new device based on QMR technology. Quantum Molecular Resonance (QMR) is a technique in which low-intensity, high-frequency electric currents are administered to a biological tissue through contact electrodes. The device applies stimulation to the epidermis of closed eyelids up to the lid margin by means of specially designed goggles. Previous studies have shown that it is relatively safe with high patient satisfaction. Preliminary studies have also shown it is effective for accelerating healing in chronic wounds and treating dry eye symptoms.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Quantum Molecular Resonance Electrotherapy in Severe Dry Eye Disease

NCT06119386

Dry Eye

COMPLETED NA

Clinical Efficacy and Molecular Dynamics of Quantum Molecular Resonance (QMR) Electrotherapy in Dry Eye Management

NCT06955806

Dry Eye Disease (DED)

ACTIVE_NOT_RECRUITING NA

Efficacy of Quantum Molecular Resonance Combined With Intense Pulsed Light in Mixed Dry Eye

NCT06576245

Dry Eye

COMPLETED NA

Proteomics Analysis of Human Tears in the Diagnosis and Management of Dry Eye Disease

NCT07175909

Dry Eye Disease (DED) Dry Eye

RECRUITING NA

A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease

NCT07078955

Dry Eye Disease (DED) Keratoconjunctivitis Sicca

NOT_YET_RECRUITING PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

In this study, the investigators aim to examine the efficacy of the Rexon eye device for the treatment of dry eye signs and symptoms in a randomized double-blind placebo-controlled fashion among a cohort of prospectively recruited patients with dry eye. The control group will receive a similar application of treatment with the device goggles disconnected from the device, effectively receiving no treatment. The treatment will be performed by research assistants following thorough instruction by the manufacturing company representatives and/or provided material. Participants will be actively questioned on any harms or side effects in every meeting.

Outcomes will be assessed based on clinical signs and by validated questionnaires on dry eye symptoms (OSDI).

Informed written consent will be obtained from all participants involved in the study prior to enrollment. The goal of the study is to evaluate the Rexon device as a possible additional treatment option for patients with dry eye or to establish it has no added benefit.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The patient does not know wheater they are on treatment or placebo arm.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Treatment

Pre-treatment medical examination by an ophthalmologist and self-filled questionnaire.

Four treatment sessions. Each session includes 20 minutes with the instrument active at power level 4. Post-treatment medical examination by an ophthalmologist and self-filled questionnaire.

Group Type ACTIVE_COMPARATOR

Rexon device

Intervention Type DEVICE

Rexon device for 20 minutes each session. A total of 4 sessions with one week apart from each other.

Placebo

Pre-treatment medical examination by an ophthalmologist and self-filled questionnaire.

Four treatment sessions. Each session includes 20 minutes with the instrument active at power level 0. Post-treatment medical examination by an ophthalmologist and self-filled questionnaire.

Group Type PLACEBO_COMPARATOR

Rexon device

Intervention Type DEVICE

Rexon device for 20 minutes each session. A total of 4 sessions with one week apart from each other.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Rexon device

Rexon device for 20 minutes each session. A total of 4 sessions with one week apart from each other.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Resono Ophthalmic

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients above the age of 18 years
* Patients who are willing and able to consent and adhere to the research plan
* Patients diagnosed with dry eye or patients who are at risk for dry eye

Exclusion Criteria

* Active infection of the eyelid or periorbital area
* Patients who are pregnant or lactating
* Patients under the age of 18
* Those scheduled for (\<30 days) or immediately after (\<30 days) ocular surgery (excluding cataract and eyelid surgery)
* Patient who do not adhere to all four treatment sessions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No