Not Yet RecruitingNot Applicable

Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction

20 participantsStarted 2026-02-20

Plain-language 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.

Who can participate

Age range18 Years – 120 Years

SexALL

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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

What they're measuring

Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks

Timeframe: Baseline to 4 weeks after final treatment

Trial details

NCT IDNCT07415330

SponsorDemaod Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Hila Kfir

972-523313350 hila.k@demaod-med.com

View on ClinicalTrials.gov More Dry Eye trials