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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Lacrima VR System (Device)
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.
干预措施: Lacrima VR System (Device)
结局指标
主要结局
Change From Baseline in Tear Break-Up Time (TBUT) at 4 Weeks
时间窗: 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.
次要结局
- 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)