---
title: Quantum Molecular Resonance Effects on Patients With Dry Eye Disease
nct_id: NCT05469932
overall_status: UNKNOWN
phase: NA
sponsor: Assaf-Harofeh Medical Center
study_type: INTERVENTIONAL
primary_condition: Dry Eye Syndromes
countries: Israel
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05469932.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05469932"
ct_last_update_post_date: 2022-07-22
last_seen_at: "2026-05-12T07:24:53.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Quantum Molecular Resonance Effects on Patients With Dry Eye Disease

**NCT ID:** [NCT05469932](https://clinicaltrials.gov/study/NCT05469932)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 50
- **Lead Sponsor:** Assaf-Harofeh Medical Center
- **Conditions:** Dry Eye Syndromes
- **Start Date:** 2021-02-14
- **Completion Date:** 2022-12
- **CT.gov Last Update:** 2022-07-22

## Brief Summary

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.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Treatment** (ACTIVE_COMPARATOR) — 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.
- **Placebo** (PLACEBO_COMPARATOR) — 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.

## Interventions

- **Rexon device** (DEVICE) — Rexon device for 20 minutes each session. A total of 4 sessions with one week apart from each other.

## Primary Outcomes

- **Change in Ocular Surface Disease Index (OSDI) Questionnaire** _(time frame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))_ — A validated questionnaire that assess the symptoms of ocular irritation in dry eye disease. and how they affect functioning related to vision. This 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient's life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to "none of the time" and 4 corresponding to "all of the time." A final score is calculated which ranges from 0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease

## Secondary Outcomes

- **Change in Meibomian gland dysfunction Grading** _(time frame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))_
- **Change in Corneal Staining** _(time frame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))_
- **Change in Tear breakup time** _(time frame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))_
- **Change in Schirmer with anesthesia** _(time frame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))_
- **Change in Corrected visual acuity** _(time frame: At baseline (pre-intervention) and up to 4 weeks after treatment ends (after-intervention))_

## Locations (1)

- Shamir Medical Center, Tel Aviv, Israel — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.shamir medical center|tel aviv||israel` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05469932.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05469932*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*