Lacrima VR for Dry Eye Disease and Meibomian Gland Dysfunction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorDemaod Ltd
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lacrima VR System
DeviceThis 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Active Lacrima VRExperimental treatment 1 intervention
Group B: Sham ControlPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to 4 weeks after final treatmentSecondary outcomes
1
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.
Time frame
Baseline to 10 weeks after final treatment2
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
Time frame
Baseline to 4 weeks and 10 weeks after final treatment3
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.
Time frame
Adverse events will be assessed from baseline (first treatment) and 10 weeks (±7 days) after their final treatment4
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.
Time frame
Baseline to 4 and 10 weeks after final treatmentLocations
Source ClinicalTrials.gov
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