Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorDemaod Ltd

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Lacrima VR System

Treatment groups

20 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Demaod Ltd

Lead sponsor