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 groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov