NCT03248440已完成3 期
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of SUN-131 Transdermal System (TDS) as Compared to Placebo TDS in Patients With a Chalazion (SUN-131-03)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1
研究概览
简要总结
This protocol for SUN-131 1.5% TDS is developed for the treatment of chalazion. SUN-131 1.5% TDS is designed for local delivery of a corticosteroid, to the upper or lower eyelid. The purpose of this study is to evaluate the efficacy and safety of SUN-131 1.5% TDS as compared with placebo TDS in the treatment of a chalazion.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥ 6 years of either sex and of any race
- •Subjects with a diagnosis of a single chalazion
- •Subjects with chalazion erythema score of ≥ 1
- •Normal eyelid function without active signs of eye and eyelid infection in either eye.
- •Must be willing and able to correctly apply and wear a transdermal patch to the eyelid
- •Avoid wearing contact lenses in the study eye
排除标准
- •Chalazion that has atypical features (a recurring chalazion at the same spot, abnormal surrounding lid tissue, associated loss of tissues).
- •History of chalazion incision and curettage in study eyelid.
- •Multiple chalazia in any one eyelid.
- •Active ocular or eyelid infection Presence of hordeolum in any one eyelid.
- •An abnormal skin condition on the study eyelid region (e.g., eczema, psoriasis, atopic dermatitis, etc.) where the study drug will be applied.
- •Diagnosed with glaucoma in either eye.
- •History of steroid-induced elevation of IOP.
- •Female subjects who are pregnant or lactating.
研究组 & 干预措施
SUN-131 1.5% TDS
Experimental
干预措施: SUN-131 1.5% TDS (Drug)
Placebo TDS
Placebo Comparator
干预措施: Placebo TDS (Drug)
结局指标
主要结局
The Proportions of Participants Who Experienced Complete Response of the Study Chalazion by Day 15 ± 1
时间窗: Baseline to Day 15 ± 1
Complete response was defined as the absence of any significant clinical signs of a chalazion, based on clinical judgment by an investigator.
次要结局
- The Proportions of Participants Who Experienced Complete Response of the Study Chalazion With Upper Eyelid by Day 15 ± 1(Baseline to Day 15 ± 1)
研究者
研究点 (1)
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