Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction

Starting soon · Not applicable · Has a placebo group

Conditions studied: Dry Eye, Dry Eye Syndromes

In brief

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.

Key facts

Study ID

NCT07415330

Run by

Demaod Ltd

People needed

20

Starts

2026-07-20

Expected to finish

2026-09-01

Last updated by the study team

2026-05-12

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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