Randomized Clinical Trial for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 139
- 试验地点
- 11
- 主要终点
- Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
研究概览
简要总结
The objective of this study is to evaluate the clinical utility, safety and effectiveness of the Manual Mini System compared to standardized warm compress therapy for application of controlled, localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye, and chalazia.
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 of age.
- •Meibomian gland obstruction
- •Dry eye symptoms
- •Willingness to comply with study procedures and return for all visits
排除标准
- •Ocular surgery, injury, or herpes infection within past 3 months
- •Active ocular infection
- •Active ocular inflammation or recurrent inflammation within past 3 months
- •Moderate to severe allergic conjunctivitis
- •Severe eyelid inflammation
- •Eyelid abnormalities that affect lid function
- •Ocular surface abnormalities that may compromise corneal integrity
- •Macular disease
- •Systemic disease condition or medication that causes dry eye
- •Use of other treatments for meibomian gland dysfunction or dry eye
- •Pregnant or nursing women
- •Participation in another ophthalmic clinical trial within past 30 days
结局指标
主要结局
Meibomian Gland Assessment (Total Meibomian Gland Secretion Score)
时间窗: Baseline, 2 Weeks and 4 Weeks
Evaluation of secretion characteristics from the gland orifices along the lower eyelid. Assessment was based on the grading scale: 3 (clear liquid secretion), 2 (cloudy liquid secretion), 1 (inspissated), 0 (no secretion). The total meibomian gland secretion score was the sum of the grades for all 15 glands with a range of 0 to 45.
Incidence of Device-related Adverse Events
时间窗: Baseline through 4 Weeks
Number of eyes for which a device-related AE occurred
Tear Break-up Time
时间窗: Baseline, 2 Weeks and 4 Weeks
Tear break-up time measured under a slit lamp biomicroscope following instillation of fluorescein dye in the eye. Time was measured in seconds with a maximum of 20. Higher tear break-up time indicates better tear film stability.
次要结局
- Dry Eye Symptoms (Total SPEED Score)(Baseline, 2 Weeks and 4 Weeks)
- Ocular Surface Staining (Corneal Staining Sum Score)(Baseline through 4 Weeks)
- Intraocular Pressure(Baseline through 4 Weeks)
- (LogMAR) Best Spectacle Corrected Visual Acuity(Baseline, 2 Weeks and 4 Weeks)
- Discomfort Evaluation (Discomfort/Pain Score)(Treatment and 1 Day)