A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 670
- 试验地点
- 4
- 主要终点
- NEI score for Total Corneal Fluorescein Staining (TCFS)
研究概览
简要总结
This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.
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
- 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
- •Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
- •Are ≥ 18 years of age;
- •Are willing and able to follow instructions and can be present for the required study visits for the duration of the study;
- •Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis
- •Have normal lid anatomy.
- •If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1
排除标准
- •Have signs of infection (i.e., fever or current treatment with antibiotics)
- •Have been exposed to an investigational drug/device within the preceding 30 days
- •Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
- •Be unwilling to or unable to comply with the study
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: Active Comparator EBI-005 (Drug)
Placebo Comparator
One of two study arms: placebo topical administered 3 times per day.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
NEI score for Total Corneal Fluorescein Staining (TCFS)
时间窗: 3 months
To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining \[sign\] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI \[symptom\] of DED from baseline to Week 12 as compared to vehicle control.
次要结局
- The key secondary endpoint is total OSDI score(3 months)