A Phase 2, Randomized, Prospective, Double-masked, Vehicle-controlled Study to Assess the Efficacy and Safety of Nexagon® (NEXAGON) in Subjects With Corneal Persistent Epithelial Defects
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.
研究概览
简要总结
This study will enroll participants with a non-infected, corneal persistent epithelial defect (PED) resulting from an ocular chemical and/or thermal ocular injury which is non-responsive or refractory to current standard of care for at least 14 days. It will assess the efficacy and safety of Nexagon® (lufepirsen) plus standard of care versus NEXAGON-vehicle (placebo) plus standard of care. The recovery of the corneal epithelium will be the primary outcome measure, defined as a cornea that re-epithelializes by Day 28 of treatment and remains re-epithelialized for at least a further 28 days.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female of any age.
- •The presence of a non-infected, corneal persistent epithelial defect (PED) which has resulted from a severe chemical and/or thermal (burn) injury to one or both eyes.
- •The PED is non-responsive to current standard of care for at least 14 days from injury.
- •The PED measures at least 2 mm along the largest diameter at Day 1 of the Treatment Period.
- •Providing written informed consent and ability to comply with the visit and dosing schedule.
排除标准
- •Have active ocular infection.
- •Subjects with corneal perforation or impending corneal perforation.
- •Subjects with any other past or present ophthalmic disease or medical condition that, in the Investigator's opinion, may affect the safety of the subject or the outcome of the study.
- •Subjects with severe lid abnormalities or ocular conditions that contribute to the persistence of the epithelial defect.
- •Female subjects of childbearing potential who are pregnant, nursing, planning a pregnancy or not using an adequate and medically acceptable form of birth control.
- •Subjects who have participated in an interventional clinical trial within 30 days prior to Day 1.
研究组 & 干预措施
Nexagon® (lufepirsen) High Dose Concentration
干预措施: Nexagon® (lufepirsen) High Dose Concentration (Drug)
Nexagon® (lufepirsen) High Dose Concentration
干预措施: Open-label Nexagon® (lufepirsen) (Drug)
Nexagon® (lufepirsen) Low Dose Concentration
干预措施: Nexagon® (lufepirsen) Low Dose Concentration (Drug)
Nexagon® (lufepirsen) Low Dose Concentration
干预措施: Open-label Nexagon® (lufepirsen) (Drug)
Vehicle
干预措施: Vehicle (Drug)
Vehicle
干预措施: Open-label Nexagon® (lufepirsen) (Drug)
结局指标
主要结局
The Proportion of Subjects Achieving Corneal Epithelial Recovery, as Assessed by Slit Lamp Examination.
时间窗: Up to 56 days.
Corneal epithelial recovery, defined as corneal reepithelialization and maintenance of a durable epithelium for at least 28 days, will be assessed by slit lamp examination.
Incidence of Treatment Emergent Adverse Events as Assessed by CTCAE v 5.0
时间窗: Up to 30 days after last application of intervention
Incidence of Treatment Emergent Adverse Events as assessed by CTCAE v 5.0.
次要结局
未报告次要终点