Comparison Between iLux and LipiFlow in the Treatment of Meibomian Gland Dysfunction (MGD): A 12-month, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 299
- 试验地点
- 30
- 主要终点
- Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
研究概览
简要总结
The purpose of this post-approval study is to demonstrate that iLux treatment offers comparable treatment effectiveness to LipiFlow for MGD treatment at 12 months post single treatment.
详细描述
Subjects will be expected to attend a total of 8 study visits, including Screening/Baseline, Treatment, and follow-up visits at Week 2 and Months 1, 3, 6, 9, and 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and sign an Informed Consent document;
- •Have Meibomian Gland Dysfunction with evaporative dry eye disease at the screening visit;
- •Agree not to wear contact lenses for the duration of the study;
- •Other protocol-specified inclusion criteria may apply.
- •Exclusion Criteria
- •History of eye surgery, as specified in the protocol;
- •Eye infection or inflammation, as specified in the protocol;
- •Eyelid abnormalities; eyelid tattoos;
- •Treated with LipiFlow or iLux in either eye in the last 12 months;
- •Contact lens wear within the 1 month prior to Screening;
- •Other protocol-specified exclusion criteria may apply.
排除标准
- 未提供
结局指标
主要结局
Least Squares Mean Change From Baseline in Meibomian Gland Score (MGS) at Month 12
时间窗: Baseline, Month 12
Meibomian glands on the eyelids were assessed by the examiner using a Meibomian Gland Evaluator and a slit lamp microscope. 5 glands in 3 zones (nasal, medial, temporal) were evaluated for each eye and scored from 0 to 3, with a resultant overall score (MGS) of 0 to 45 for each eye. Scoring was follows: 0 = no secretion (worst), 1 = inspissated, 2 = cloudy, 3 = clear liquid (best). A higher change from baseline score indicates an improvement in meibomian gland function.
次要结局
未报告次要终点