Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07415330

Lacrima VR for 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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

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

    Time frame: 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.

  2. Change From Baseline in Ocular Surface Disease Index (OSDI)

    Time frame: 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

  3. 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

    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.

  4. Changes in Intraocular Pressure (IOP)

    Time frame: 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.

  5. Changes in Best Corrected Visual Acuity (BCVA)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hila Kfir

CONTACT

[email protected]

972-523313350

Ronen Shavit

CONTACT

[email protected]

972-522420798

Sponsors and collaborators

Lead sponsor

Demaod Ltd

Industry

Registry information

Official study 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

Acronym: CLN-0154

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.