Dry Eye, Dry Eye Syndromes
Conditions
Brief 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.
Detailed description
Dry Eye Disease (DED) and Meibomian Gland Dysfunction (MGD) are common ocular surface disorders associated with tear film instability, ocular discomfort, and impaired visual function. The Lacrima VR system is a non-invasive medical device that delivers controlled sequences of light pulses using virtual reality technology, intended to activate reflex pathways associated with lacrimal and meibomian gland function. This randomized, evaluator-masked study compares the Lacrima VR system with a sham device that is identical in appearance but operates at substantially reduced luminance. Subjects will undergo four treatment sessions at two-week intervals, followed by follow-up visits at 4 and 10 weeks after the final treatment. Effectiveness will be assessed using objective measures (TBUT) and patient-reported outcomes (OSDI). Safety assessments will include monitoring of adverse events, intraocular pressure, visual acuity, and discomfort questionnaires.
Interventions
DEVICELacrima 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.
Sponsors
Demaod Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
This study is single-masked. Outcome assessors are masked to treatment allocation. Participants are randomized to receive either the active Lacrima VR system or a sham device that is identical in appearance but operates at a reduced luminance. The evaluator performing objective outcome assessments, including Tear Break-Up Time (TBUT), is not involved in treatment administration and is not exposed to treatment sessions. Study personnel responsible for device setup and treatment delivery are not masked.
Intervention model description
Parallel Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks | Baseline to 4 weeks after final treatment | Change from baseline to the 4-week follow-up in Tear Break-Up Time (TBUT) will be assessed as an objective measure of tear film stability. TBUT will be measured in seconds using fluorescein dye by a masked evaluator who is not involved in treatment administration. The outcome is defined as the change from baseline in TBUT at specified follow-up visits, with measurements averaged across repeated assessments per eye.ear Break-Up Time (TBUT), measured in seconds by a masked evaluator. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Tear Break-Up Time (TBUT) at 10 Weeks | Baseline to 10 weeks after final treatment | Tear Break-Up Time (TBUT) will be assessed as an objective measure of tear film stability. TBUT will be measured in seconds using fluorescein dye by a masked evaluator who is not involved in treatment administration. The outcome is defined as the change from baseline in TBUT at specified follow-up visits, with measurements averaged across repeated assessments per eye. |
| Change From Baseline in Ocular Surface Disease Index (OSDI) | Baseline to 4 weeks and 10 weeks after final treatment | Patient-reported symptoms assessed using theThe Ocular Surface Disease Index (OSDI) will be used to evaluate patient-reported symptoms related to dry eye disease and their impact on visual function and quality of life. The OSDI is a validated 12-item questionnaire, with scores ranging from 0 to 100, where higher scores indicate greater symptom severity. The outcome is defined as the change from baseline in OSDI score at follow-up visits. validated OSDI questionnaire |
| Incidence of Device-Related Adverse Events | Adverse events will be assessed from baseline (first treatment) and 10 weeks (±7 days) after their final treatment | The incidence, nature, severity, and relationship to the investigational device of all adverse events will be assessed throughout the study. Adverse events will be collected from the first treatment session through the final follow-up visit and categorized as device-related or non-device-related. Serious adverse events and unanticipated adverse device effects will be recorded and reported according to applicable regulatory requirements. |
| Changes in Intraocular Pressure (IOP) | Baseline to 4 and 10 weeks after final treatment | Intraocular Pressure (IOP) will be measured in millimeters of mercury (mmHg) using standard clinical tonometry. IOP assessments will be conducted at baseline and at follow-up visits to monitor ocular safety. The outcome is defined as the change from baseline in IOP values following treatment. |
| Changes in Best Corrected Visual Acuity (BCVA) | Baseline to 4 and 10 weeks after final treatment | Best Corrected Visual Acuity (BCVA) will be assessed using standardized visual acuity testing under best spectacle correction. BCVA measurements will be recorded at baseline and follow-up visits to evaluate any changes in visual function. The outcome is defined as the change from baseline in BCVA following treatment. |
Contacts
CONTACTHila Kfir
CONTACTRonen Shavit
PRINCIPAL_INVESTIGATORmichael Mimouni, Prof - Ophthalmology
Rambam Campus medical center
Outcome results
None listed