NCT04498169已完成2 期
A Randomized, Open-Label, Parallel-Group Study to Evaluate the Safety and Efficacy of Two Dosing Regimens of Netarsudil Ophthalmic Solution in Patients With Corneal Edema Due to Fuchs Corneal Dystrophy
Aerie Pharmaceuticals11 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年9月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 11
- 主要终点
- Central Corneal Thickness (CCT)
研究概览
简要总结
Two different dosing regimens (QD and BID) of netarsudil will be studied to evaluate their efficacy in reducing or resolving corneal edema in subjects with FCD.
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
- 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
- •Adults aged 18 years or older
- •Documented diagnosis of FCD
- •Evidence of central corneal edema, in at least one eye, at the Screening and Baseline Visit, in the eligible eye(s)
- •Reduced BCVA secondary to central corneal edema, at Screening and Baseline, in the eligible eye(s)
排除标准
- •FCD so advanced that, in the opinion of the Investigator, surgery would likely be required in the study eligible eye(s) within the study period
- •Clinically significant ocular disease (other than FCD) or trauma in the eligible eye(s) which could interfere with study interpretation
- •History of ocular surgery within 6 months of the Screening Visit, or any prior corneal refractive surgery in the eligible eye(s)
研究组 & 干预措施
Once Daily Netarsudil Ophthalmic Solution
Experimental
One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the evening for an 8 week period in up to 20 subjects.
干预措施: Netarsudil Ophthalmic (Drug)
Twice Daily Netarsudil Ophthalmic Solution
Experimental
One drop of Netarsudil 0.02% ophthalmic solution in the study eye in the morning and in the evening for an 8 week period in up to 20 subjects.
干预措施: Netarsudil Ophthalmic (Drug)
结局指标
主要结局
Central Corneal Thickness (CCT)
时间窗: Baseline & 4 weeks
Mean change from baseline in CCT by ultrasound pachymetry
次要结局
未报告次要终点
研究者
研究点 (11)
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