NCT04469998已完成2 期
A Phase I/II, Randomized, Double-Masked, Vehicle-Controlled Study of the Safety, Tolerability, and Efficacy of AXR-270 Topical Eyelid Cream in Treating Posterior Blepharitis Associated With Meibomian Gland Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)
详细描述
AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270 cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis associated with meibomian gland dysfunction
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years or older
- •Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate))
- •Have a score of ≥35 on Eye Discomfort using VAS
- •Have a tFCS score between 3 and 14 on the NEI scale
- •Have a Schirmer score of >7 mm
- •Have a OSDI score >30
- •If female, then subject should be non-pregnant and non-lactating
排除标准
- •Subjects with iritis, uveitis in either eye
- •Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD
- •Subjects with lid abnormalities
- •Subjects with ocular fungal, viral or bacterial infection
- •Subjects unable or unwilling to withhold the use of eyelid scrubs
- •Subjects with glaucoma and serious systemic disease
研究组 & 干预措施
AXR-270 Low Dose
Experimental
AXR-270 Low Dose administered once daily
干预措施: AXR-270 Low Dose (Drug)
AXR-270 High Dose
Experimental
AXR-270 High Dose administered once daily
干预措施: AXR-270 High Dose (Drug)
AXR-270 Vehicle
Placebo Comparator
AXR-270 Vehicle administered once daily
干预措施: AXR-270 Vehicle (Drug)
结局指标
主要结局
Adverse Events
时间窗: 22 Days
Incidence of treatment emergent ocular and systemic adverse events (TEAE)
次要结局
- Total Meibomian Gland Dysfunction Score(22 Days)
研究者
研究点 (1)
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