MedTrace Logo

Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction

NCT07415330 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-05-12

No results posted yet for this study

Summary

This is a prospective, multi-center, randomized, sham-controlled clinical investigation designed to evaluate the safety and effectiveness of the Lacrima VR system in adult subjects with Dry Eye Disease (DED) and Meibomian Gland Dysfunction (MGD). Subjects will be randomized in a 1:1 ratio to receive either active Lacrima VR treatment or a sham device with reduced luminance. Effectiveness will be assessed primarily by change in Tear Break-Up Time (TBUT), and safety will be evaluated by the incidence of device-related adverse events.

Conditions

  • Dry Eye
  • Dry Eye Syndromes

Interventions

DEVICE

Lacrima VR System

This is a prospective, randomized, sham-controlled, evaluator-masked clinical investigation designed to evaluate the safety and effectiveness of the Lacrima VR system in adult subjects with Dry Eye Disease (DED) and Meibomian Gland Dysfunction (MGD). Eligible participants will be randomized in a 1:1 ratio to receive either active Lacrima VR treatment or a sham device with reduced luminance. The intervention consists of four non-invasive treatment sessions administered at two-week intervals using a virtual reality headset that delivers controlled sequences of light pulses. All participants will undergo standardized ophthalmic assessments and patient-reported outcome evaluations at baseline and at predefined follow-up visits conducted 4 and 10 weeks after the final treatment session. Safety will be assessed throughout the study by monitoring adverse events, discomfort, and changes in ocular parameters.

Sponsors & Collaborators

  • Demaod Ltd

    lead INDUSTRY

Principal Investigators

  • michael Mimouni, Prof - Ophthalmology · Rambam Campus medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2026-08-01
Completion
2026-09-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07415330 on ClinicalTrials.gov