ACTRN12619001724167撤回1 期
A Phase 1b, Open-Label, Single-Arm Study to Evaluate the Safetyand Efficacy of CMB-012 in Subjects with Chemical Burns of theCornea and/or Persistent Corneal Epithelial Defects (PCED)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Participants with persistent corneal epithelial defect (PCED) of at least 10 days refractory to one or more conventional non-surgical treatments in study eye (e.g., preservative-free artificial tears, gels or ointments; therapeutic contact lenses).
- •Participants with corneal burns occurring within 24 hours prior to commencement of intervention.
排除标准
- •Participants with severe eyelid abnormalities contributory to the persistence of the persistent corneal epithelial defect (PCED).
- •Any active ocular infection (bacterial, viral, fungal or protozoal) based on corneal and bacterial cultures taken during the screening period.
- •More than one distinct PCED in the study eye.
- •Evidence of corneal ulceration involving the posterior third of the corneal stroma, corneal melting or perforation in the study eye
- •Presence or history of any ocular or systemic disorder or condition that may hinder the efficacy of the study treatment or its evaluation, could possibly interfere with the interpretation of study results, or could be judged by the Investigator to be incompatible with the study visit schedule or conduct (e.g., progressive or degenerative corneal or retinal conditions, uveitis, optic neuritis, poorly controlled diabetes, autoimmune disease, systemic infection, neoplastic diseases).
研究者
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