Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction

NCT07415330 | Not Yet Recruiting

• 1 other identifier: CLN 0154
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dry Eye; Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change From Baseline in Tear Break-Up Time (TBUT) at 10 Weeks

  Baseline to 10 weeks after final treatment

• Change From Baseline in Ocular Surface Disease Index (OSDI)

  Baseline to 4 weeks and 10 weeks after final treatment

• Incidence of Device-Related Adverse Events

  Adverse events will be assessed from baseline (first treatment) and 10 weeks (±7 days) after their final treatment

• Changes in Intraocular Pressure (IOP)

  Baseline to 4 and 10 weeks after final treatment

• Changes in Best Corrected Visual Acuity (BCVA)

  Baseline to 4 and 10 weeks after final treatment

Study Arms (2)

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.

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.

Device: Lacrima VR System

Interventions

Lacrima VR System DEVICE

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.

Active Lacrima VR; Sham Control

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Demaod Ltd: lead

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• michael Mimouni, Prof - Ophthalmology

  Rambam Campus medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hila Kfir

CONTACT

972-523313350; hila.k@demaod-med.com

Ronen Shavit

CONTACT

972-522420798; ronen.s@demaod-med.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: February 17, 2026
• Study Start (Estimated): July 20, 2026
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share