NCT04169061已完成4 期
A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mallinckrodt
- 入组人数
- 36
- 试验地点
- 9
- 主要终点
- Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
研究概览
简要总结
We will need about 36 participants for this study.
Volunteers might be able to participate if:
- they have bad noninfectious keratitis
- early treatments failed or were not well tolerated
Participants will be in the study for about 22 weeks:
- 4 weeks for tests to see if the study might be good for them
- 12 weeks of treatment with Acthar gel
- 4 weeks to wean off Acthar gel and follow-up with the doctor
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Has severe or recalcitrant keratitis
- •Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
- •If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
- •Has normal eyelids, and protocol-defined physical and medical eye attributes
- •Agrees to avoid wearing contact lenses during the trial
排除标准
- •Is pregnant or breast-feeding
- •Is defined as vulnerable, or is employed by, or related to anyone involved in the study
- •Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis
研究组 & 干预措施
All participants
Experimental
Participants receive:
- a shot of Acthar (80 units) under the skin twice a week for 12 weeks
- a shot of Acthar (40 units) twice a week for 2 weeks
- a shot of Acthar (40 units) once a week for 2 more weeks
At each visit they will have medical tests and answer questions about their symptoms.
干预措施: Acthar (Drug)
结局指标
主要结局
Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
时间窗: Week 12
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.
次要结局
未报告次要终点
研究者
研究点 (9)
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