A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Evaluation of the Efficacy, Safety, and Tolerability of EBI-005 in Subjects With Moderate to Severe Ocular Allergic Conjunctivitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Morning ocular itching diary scores
研究概览
简要总结
This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.
Approximately 250 subjects at approximately 8 centers in the US will be screened and 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 authorization required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
- •Are ≥18 years of age;
- •Have a positive history of ocular allergies during ragweed pollen season;
- •Have signs and symptoms of allergic conjunctivitis in both eyes;
- •If female and of child-bearing potential, she must not be pregnant or lactating
排除标准
- •Have signs of ocular infection;
- •Have a known history of alcohol or drug abuse;
- •Have been exposed to an investigational drug or device within 30 days of the study;
- •Have planned surgery (ocular or systemic) during the trial period or within 30 days after
研究组 & 干预措施
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)
Vehicle
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
Morning ocular itching diary scores
时间窗: 14 days
To evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season.
次要结局
- Late afternoon ocular itching diary scores(14 days)
- Evening ocular itching diary scores(14 days)