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Not yet recruiting NCT07415330

Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction

No phase Interventional Dry Eye Dry Eye Syndromes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lacrima VR System.
Who it may be relevant to
Registry conditions: Dry Eye, Dry Eye Syndromes. Basic parameters: 18 years — 120 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Randomized, Masked (Evaluator), Sham-Controlled, Prospective Study to Evaluate the Safety and Effectiveness of the Lacrima VR System in Subjects With Dry Eye Disease and Meibomian Gland Dysfunction

Overview

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.

Detailed description

Dry Eye Disease (DED) and Meibomian Gland Dysfunction (MGD) are common ocular surface disorders associated with tear film instability, ocular discomfort, and impaired visual function. The Lacrima VR system is a non-invasive medical device that delivers controlled sequences of light pulses using virtual reality technology, intended to activate reflex pathways associated with lacrimal and meibomian gland function.

This randomized, evaluator-masked study compares the Lacrima VR system with a sham device that is identical in appearance but operates at substantially reduced luminance. Subjects will undergo four treatment sessions at two-week intervals, followed by follow-up visits at 4 and 10 weeks after the final treatment. Effectiveness will be assessed using objective measures (TBUT) and patient-reported outcomes (OSDI). Safety assessments will include monitoring of adverse events, intraocular pressure, visual acuity, and discomfort questionnaires.

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

Primary outcome measures

  • Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks [Time frame: Baseline to 4 weeks after final treatment]
Secondary outcome measures (5)
  • Change From Baseline in Tear Break-Up Time (TBUT) at 10 Weeks [Time frame: Baseline to 10 weeks after final treatment]
  • Change From Baseline in Ocular Surface Disease Index (OSDI) [Time frame: Baseline to 4 weeks and 10 weeks after final treatment]
  • Incidence of Device-Related Adverse Events [Time frame: Adverse events will be assessed from baseline (first treatment) and 10 weeks (±7 days) after their final treatment]
  • Changes in Intraocular Pressure (IOP) [Time frame: Baseline to 4 and 10 weeks after final treatment]
  • Changes in Best Corrected Visual Acuity (BCVA) [Time frame: Baseline to 4 and 10 weeks after final treatment]

Eligibility criteria

Inclusion criteria

  • Adults aged 18 years and older
  • Ability to provide written informed consent
  • Willingness and ability to comply with study procedures and visits
  • Self-reported dry eye symptoms for at least 3 months
  • OSDI score ≥ 23 at baseline
  • Tear Break-Up Time (TBUT) < 10 seconds in both eyes

Exclusion criteria

  • Ocular surgery within 1 year prior to screening
  • Active ocular infection or inflammation
  • History of ocular herpes infection within the past 3 months
  • Use of contact lenses within 3 months prior to screening or during the study
  • Use of prohibited dry eye or MGD treatments within protocol-defined washout periods
  • Diagnosis of epilepsy
  • Intraocular pressure > 20 mmHg
  • Pregnancy or breastfeeding

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07415330 · CLN 0154

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗