Randomized Controlled Trial of Long-term Treatment Effectiveness for Meibomian Gland Dysfunction (MGD) and Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months
研究概览
简要总结
The study objective is to evaluate the long-term treatment effectiveness for adult patients with meibomian gland dysfunction (MGD) and evaporative dry eye by: 1) comparing the LipiFlow® System to a standardized daily warm compress and eyelid hygiene control therapy over a duration of 3 Months; and 2) evaluating the LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months.
This is a post-market, non-significant risk, prospective and multi-center clinical trial divided into two stages. The first stage from enrollment to 3 Months is an open-label, randomized controlled design to compare the effectiveness of a single LipiFlow® System treatment to a standardized daily warm compress and eyelid hygiene Control therapy with Crossover LipiFlow® treatment of the Control subjects at 3 Months. The second stage, occurring between 3 and 12 Months, is an observational design to evaluate the effectiveness of LipiFlow® alone and in combination with other MGD and dry eye treatments over a duration of up to 12 Months. Subjects are entered into the following subgroups based on the subject's self-assessment of the adequacy of symptom relief and protocol-defined criteria for additional treatment.
- One LipiFlow® Treatment: Subjects who receive only one LipiFlow® treatment.
- Two LipiFlow® Treatments: Subjects who receive a second LipiFlow® treatment.
- Combination Treatment: Subjects who receive one or two LipiFlow® treatments followed by other MGD or dry eye treatment, as prescribed by the physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •At least 18 years old
- •Tear film assessment that qualifies in both eyes
- •Evidence of meibomian gland dysfunction and dry eye in both eyes
- •Willingness to comply with study protocol
排除标准
- •Systemic disease condition or medication that causes dry eye
- •Use of other treatments for MGD or dry eye
- •Ocular surgery, trauma, herpes infection, punctal plug insertion or punctal occlusion within past 3 months
- •Active eye infection
- •Active eye inflammation or recurrent inflammation within past 3 months
- •Moderate to severe allergic conjunctivitis
- •Severe eyelid inflammation
- •Eyelid abnormality that affects lid function
- •Ocular surface abnormality that may compromise corneal integrity
- •Pregnant or nursing women
- •Participation in another ophthalmic clinical trial within past 30 days
结局指标
主要结局
Stage 1 Mean Change in Total Meibomian Gland Score From Baseline to 3 Months
时间窗: Baseline and 3 Months
To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. To be eligible for the study, the Baseline total meibomian gland score must have been 12 or less in each eye. Change = 3 Month score - Baseline Score.
Stage 2 Mean Total Meibomian Gland Score at 12 Months
时间窗: 12 Months
To assess the meibomian glands, the secretion characteristics from 15 gland orifices along the lower eyelid were evaluated under a slit lamp biomicrosope using a handheld instrument, Meibomian Gland Evaluator, to apply gentle standardized pressure to the eyelid margin. Expressed secretion characteristics were graded on a scale of 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated/toothpaste consistency), and 0 (no secretion). Total meibomian gland score was calculated based on the sum of the secretion grades for all 15 glands over a range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction. The total meibomian gland score at 12 Months was compared across subgroups, as defined below.
次要结局
- Stage 1 Mean Change in Total OSDI Score From Baseline to 3 Months(Baseline, 3 Months)
- Stage 2 Mean Total OSDI Score at 12 Months(12 Months)