[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624876":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":31,"locations":25,"responsibleParty":41,"collaborators":25,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":25,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":25,"overallStatus":64,"whyStopped":25,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":25},{"fullName":5,"class":6},"Demaod Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active Lacrima VR","EXPERIMENTAL","Participants receive treatment using the Lacrima VR headset delivering controlled light pulse sequences at a luminance of approximately 125 cd\u002Fm². Four treatment sessions are administered at two-week intervals.",[13],"Device: Lacrima VR System",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Control","PLACEBO_COMPARATOR","Participants receive treatment using an identical Lacrima VR headset operating at reduced luminance (approximately 25 cd\u002Fm²). Four treatment sessions are administered at two-week intervals.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Lacrima VR System","This is a prospective, randomized, sham-controlled, evaluator-masked 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). Eligible participants will be randomized in a 1:1 ratio to receive either active Lacrima VR treatment or a sham device with reduced luminance. The intervention consists of four non-invasive treatment sessions administered at two-week intervals using a virtual reality headset that delivers controlled sequences of light pulses. All participants will undergo standardized ophthalmic assessments and patient-reported outcome evaluations at baseline and at predefined follow-up visits conducted 4 and 10 weeks after the final treatment session. Safety will be assessed throughout the study by monitoring adverse events, discomfort, and changes in ocular parameters.",[9,15],null,[27],{"name":28,"affiliation":29,"role":30},"michael Mimouni, Prof - Ophthalmology","Rambam Campus medical center","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":25,"email":36},"Hila Kfir","CONTACT","972-523313350","hila.k@demaod-med.com",{"name":38,"role":34,"phone":39,"phoneExt":25,"email":40},"Ronen Shavit","972-522420798","ronen.s@demaod-med.com",{"type":42,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100624876","lacrima-vr-for-dry-eye-disease-and-meibomian-gland-dysfunction-100624876",false,"NCT07415330","Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction","A Randomized, Masked (Evaluator), Sham-Controlled, Prospective Study to Evaluate the Safety and Effectiveness of the Lacrima VR System in Subjects With Dry Eye Disease and Meibomian Gland Dysfunction","CLN-0154","Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Ability to provide written informed consent\n* Willingness and ability to comply with study procedures and visits\n* Self-reported dry eye symptoms for at least 3 months\n* OSDI score ≥ 23 at baseline\n* Tear Break-Up Time (TBUT) \\\u003C 10 seconds in both eyes\n\nExclusion Criteria:\n\n* Ocular surgery within 1 year prior to screening\n* Active ocular infection or inflammation\n* History of ocular herpes infection within the past 3 months\n* Use of contact lenses within 3 months prior to screening or during the study\n* Use of prohibited dry eye or MGD treatments within protocol-defined washout periods\n* Diagnosis of epilepsy\n* Intraocular pressure \\> 20 mmHg\n* Pregnancy or breastfeeding","ALL","18 Years","120 Years",{"count":55,"type":56},20,"ESTIMATED","INTERVENTIONAL",[59],"NA","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.",[62,63],"Dry Eye","Dry Eye Syndromes","NOT_YET_RECRUITING","2026-05-11",{"date":67,"type":68},"2026-05-12","ACTUAL",{"date":70,"type":56},"2026-07-20",{"date":72,"type":56},"2026-09-01",{"name":5,"class":6}]