A Multi-Center, Double-Masked, Randomized, One-Year Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle-Control in Subjects With Dry Eye Disease (DED)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 188
- 主要终点
- Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)
研究概览
简要总结
This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Care Provider, 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
- •Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to Visit 1
- •Are willing and able to follow instructions and can be present for the required study visits for the duration of the study
排除标准
- •Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)
- •Have had penetrating intraocular surgery within 12 months prior to Visit 1
- •Be unwilling to comply with the study requirements
研究组 & 干预措施
Active Comparator: EBI-005
Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day
干预措施: EBI-005 (Drug)
Placebo or Vehicle control Comparator
One of two study arms: placebo or vehicle control topical administered 3 times per day
干预措施: Placebo (Drug)
结局指标
主要结局
Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)
时间窗: 1 year
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
Safety of EBI-005 (vital signs)
时间窗: 1 year
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
tolerability of EBI-005 (adverse events)
时间窗: 1 year
Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.
Safety of EBI-005 (laboratory changes over time)
时间窗: 1 year
次要结局
- Biological effect of EBI-005 (Total corneal fluorescein staining)(1 year)
- Biological effect of EBI-005 (Changes over time in the OSDI)(1 year)