Randomized, Controlled Trial to Evaluate the Safety and Effectiveness of the TearCare® System in the Treatment of the Signs and Symptoms of Dry Eye Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 12
- 主要终点
- Mean Change in Tear Break-Up Time From Baseline to Month 1
研究概览
简要总结
In this study, the TearCare System will be compared with standard-of-care warm compress treatment and lid massage in patients with dry eye disease. The objective is to demonstrate that the TearCare System is safe and effective in relieving the signs and symptoms of dry eye disease and that it is superior to a commonly prescribed, standard treatment of warm compress and lid massage.
NOTE: All sites have been selected for this study.
详细描述
This prospective, randomized, controlled, single-masked, multi-center treatment study will recruit 200 subjects with dry eye disease (OSDI Score of ≥23, TBUT of ≤7 seconds in both eyes, Meibomian gland obstruction in both eyes based on a total Meibomian Gland Secretion Score ≤12 in each eye and best corrected visual acuity of 20/100 or better in both eyes). Subject will be at least 22 years of age with reports of dry eye symptoms within the past 3 months, having to use artificial tears or lubricants regularly over the past month to relieve dry eye symptoms and willingness to comply with the study procedures and follow-up for 12 months.
All subjects will complete an informed consent form indicating their voluntary participation in the study.
Study Measurements will be made at baseline (Day 0 - randomization to TearCare or Warm Compress/Lid Massage) and at Day 1, Week 1, and Months 1, 3, 6, 7, 9, 12.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with dry eye disease
- •Signs and symptoms of dry eye disease
- •Best corrected visual acuity 20/100 or better
- •Willing and able to comply with study procedures
- •Willing and able to provide consent
排除标准
- •Active ocular infection or inflammation
- •History of eyelid, conjunctiva or corneal surgery within the past year.
- •Recent office-based dry eye treatment, punctal occlusion or punctal plug placement
- •Contact lens wearer
- •Significant ocular surface or eyelid abnormalities, recent ocular trauma
- •Certain corneal surface abnormalities
- •Use of medications for treatment of dry eye or medications that cause dry eye
- •Systemic disease that results in dry eye
研究组 & 干预措施
TearCare
TearCare subjects will receive TearCare thermal treatment followed by manual clearing of the meibomian glands.
干预措施: TearCare (Device)
Warm Compress & Lid Massage
Subjects will perform warm compress and lid massage at home daily.
干预措施: Warm Compress and Lid Massage (Device)
结局指标
主要结局
Mean Change in Tear Break-Up Time From Baseline to Month 1
时间窗: 1 month
The TBUT was evaluated by measuring the time to breakup of the tear film following a complete blink when viewed through the slit-lamp using a cobalt blue filter. The TBUT was recorded using a stopwatch for each eye as the average of 3 measurements at each visit. The change in TBUT was The difference between the mean baseline value and the mean Month 1 value. The TBUT for each eye for a subject was averaged. The mean change in TBUT is the Month 1 value minus the baseline value for each subject which are then averaged. An increase in TBUT is an improvement.
次要结局
- Mean Change in OSDI Score From Baseline to Month 1(1 month)