Dry EyeCLN-0154NCT07415330
Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction
A study testing Lacrima VR System in people with Dry Eye and Dry Eye Syndromes, run by Demaod Ltd.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Dry Eye, Dry Eye Syndromes
- What is being tested?
- Lacrima VR System
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2026to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Dry Eye, Dry Eye Syndromes
- Being tested
- Lacrima VR System
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lacrima VR SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active Lacrima VR | Experimental | Participants receive treatment using the Lacrima VR headset delivering controlled light pulse sequences at a luminance of approximately 125 cd/m². Four treatment sessions are administered at two-week intervals. Receives: Device: Lacrima VR System |
| Sham Control | Placebo comparator | Participants receive treatment using an identical Lacrima VR headset operating at reduced luminance (approximately 25 cd/m²). Four treatment sessions are administered at two-week intervals. Receives: Device: Lacrima VR System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks
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.
Measured: Baseline to 4 weeks after final treatment
Secondary outcomes (5)
Change From Baseline in Tear Break-Up Time (TBUT) at 10 Weeks
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.
Measured: Baseline to 10 weeks after final treatment
Change From Baseline in Ocular Surface Disease Index (OSDI)
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
Measured: Baseline to 4 weeks and 10 weeks after final treatment
Incidence of Device-Related Adverse Events
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.
Measured: Adverse events will be assessed from baseline (first treatment) and 10 weeks (±7 days) after their final treatment
Changes in Intraocular Pressure (IOP)
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.
Measured: Baseline to 4 and 10 weeks after final treatment
Changes in Best Corrected Visual Acuity (BCVA)
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.
Measured: Baseline to 4 and 10 weeks after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start20 Jul 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Demaod Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- michael Mimouni, Prof - Ophthalmology, Principal investigator, Rambam Campus medical center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07415330
- Sponsor's protocol ID
- CLN 0154
- Acronym
- CLN-0154
- Status last verified
- May 2026
- First submitted
- 29 Jan 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07415330
- Acronym / sponsor ID
- CLN-0154 / CLN 0154
- Conditions
- Dry Eye, Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Demaod LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Active Lacrima VR | Experimental | Device: Lacrima VR SystemParticipants receive treatment using the Lacrima VR headset delivering controlled light pulse sequences at a luminance of approximately 125 cd/m². Four treatment sessions are administered at two-week intervals. |
| Sham Control | Placebo comparator | Device: Lacrima VR SystemParticipants receive treatment using an identical Lacrima VR headset operating at reduced luminance (approximately 25 cd/m²). Four treatment sessions are administered at two-week intervals. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lacrima VR SystemThis 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. | Device | Active Lacrima VR, Sham Control |
Primary outcome
Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks
Time frame: 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.
5 secondary outcomes
Change From Baseline in Tear Break-Up Time (TBUT) at 10 Weeks
Time frame: Baseline to 10 weeks after final treatment
Change From Baseline in Ocular Surface Disease Index (OSDI)
Time frame: Baseline to 4 weeks and 10 weeks after final treatment
Incidence of Device-Related Adverse Events
Time frame: Adverse events will be assessed from baseline (first treatment) and 10 weeks (±7 days) after their final treatment
Changes in Intraocular Pressure (IOP)
Time frame: Baseline to 4 and 10 weeks after final treatment
Changes in Best Corrected Visual Acuity (BCVA)
Time frame: Baseline to 4 and 10 weeks after final treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
michael Mimouni, Prof - Ophthalmology principal investigator
Rambam Campus medical center
Questions about this trial
What is this clinical trial studying?
A study testing Lacrima VR System in people with Dry Eye and Dry Eye Syndromes, run by Demaod Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hila Kfir (972-523313350, hila.k@demaod-med.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks (time frame: Baseline to 4 weeks after final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.