NCT05927428招募中2 期
An Open-Label, Multi-Center, Phase 2 Dose Ranging Study of BRM424 Ophthalmic Solution in Patients With Neurotrophic Keratitis (NK)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
研究概览
简要总结
The objective of this study is to obtain initial efficacy of BRM424 in patients with Stage 2 and Stage 3 NK and evaluate safety and tolerability.
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
- •Be at least 18 years of age;
- •Provide written informed consent;
- •Patients with NK Stage 2 (PED) or Stage 3 (corneal ulcer);
排除标准
- •Any active ocular infection (bacterial, viral, fungal or protozoal) or active ocular inflammation not related to NK;
- •Anticipated need to use therapeutic contact lenses or contact lens wear for refractive correction during the 28-days Treatment Period in the eye(s) with NK;
- •Be a woman of childbearing potential who is not using an acceptable means of birth control;
研究组 & 干预措施
BRM424 Ophthalmic Solution - Dose1
Active Comparator
干预措施: BRM424 Ophthalmic Solution - Dose1 (Drug)
BRM424 Ophthalmic Solution - Dose2
Active Comparator
干预措施: BRM424 Ophthalmic Solution - Dose2 (Drug)
结局指标
主要结局
Proportion of patients achieving complete healing of the PED or corneal ulcer determined by corneal fluorescein staining
时间窗: at or before 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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