A Randomized, Multi-center, Double-masked, Vehicle-controlled, Phase 1/2 Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI (Cyclosporine Ophthalmic Insert) for Intracanalicular Use for the Treatment of Subjects With Dry Eye Disease (DED)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 3
- 主要终点
- Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
研究概览
简要总结
To assess the safety, tolerability and efficacy of a single dose of OTX-CSI, a sustained release cyclosporine drug product, in subjects with dry eye disease.
详细描述
Randomized, multi-center, double-masked, vehicle-controlled, Phase 1/2 study to evaluate the safety, tolerability, and efficacy of OTX-CSI in subjects with dry eye disease. The subjects will be followed for approximately 16 weeks after product insertion
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Dry eye disease diagnosis
- •VAS eye dryness severity score ≥ 30.
排除标准
- •Are unwilling to discontinue use of contact lenses
- •Are unwilling to withhold use of artificial tears.
研究组 & 干预措施
OTX-CSI-Cohort 1
Formulation 2A-.36 mg
干预措施: OTX-CSI (Drug)
OTX-CSI-Cohort 2
Formulation 1- .36 mg
干预措施: OTX-CSI (Drug)
HV
Cohort 2:
Formulation 2B
干预措施: Placebo Vehicle (Other)
OTX-CSI- Cohort 2
Formulation 2A- .36 mg
干预措施: OTX-CSI (Drug)
HV-2
Cohort 2:
Formulation 3
干预措施: Placebo Vehicle (Other)
结局指标
主要结局
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
时间窗: From Screening to Study Exit, approximately 156 days.
Number of Subjects With At Least One (1) Treatment Emergent Adverse Event
Schirmer Test Score, CFB at Week 12
时间窗: Change from Baseline at Week 12
A Schirmer test strip measures the amount of tear production and provides a unit of measure in millimeters (mm).
次要结局
未报告次要终点