Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction (NCT07415330) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction
20 participantsStarted 2026-07-20
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 range
18 Years – 120 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks
Timeframe: Baseline to 4 weeks after final treatment