Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction (CLN-0154)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Dry Eye Syndromes
• Intervention / Treatment: Device: Lacrima VR System

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hila Kfir; Phone Number: 972-523313350; Email: hila.k@demaod-med.com
• Study Contact Backup: Name: Ronen Shavit; Phone Number: 972-522420798; Email: ronen.s@demaod-med.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active Lacrima VR; 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.	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.
Placebo Comparator: Sham Control; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 4 weeks after final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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.	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.	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.	Baseline to 4 and 10 weeks after final treatment

Collaborators and Investigators

• Sponsor: Demaod Ltd
• Investigators: Principal Investigator: michael Mimouni, Prof - Ophthalmology, Rambam Campus medical center

Study record dates

Study Major Dates

• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: January 29, 2026
• First Submitted That Met QC Criteria: February 12, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases; Dry Eye Syndromes
• Other Study ID Numbers: CLN 0154

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No