NCT02082899已完成2 期
A Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel, Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC) Model and Conjunctival Allergen Provocation Test (CAPT) Model
Eleven Biotherapeutics1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2014年2月最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
研究概览
简要总结
This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel, Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC) Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.
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
- •Provide written informed consent prior to any study-related procedures.
- •Be 18 years of age or older.
- •Have at least a 2 year history of moderate to severe allergic conjunctivitis.
- •Have a positive skin prick test to ragweed within the past 12 months of Screening (Visit 1A).
- •Have a score of ≥ 2 for staff-assessed ocular redness in at least one region (nasal or temporal) in each eye and ≥ 2 for subject-assessed ocular itching within the 3.5-hour period of allergen exposure in the EEC at Visit 1B.
- •Have required more than one anti-allergy pharmaceutical treatments in the past 2 years to treat ocular symptoms (including oral, topical, nasal treatments).
- •Be able to self-administer topical ophthalmic drops.
- •Avoid any topical or systemic ocular medications during the entire study period.
- •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
- •Are female and of childbearing potential and unwilling to remain abstinent through 30 days following the last dose of study drug or not willing to use acceptable birth control methods.
- •Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept, or Ilaris).
- •Have a known contraindication or hypersensitivities to Anakinra (Kineret®) or any therapeutic agent targeted to IL-1 or any component of study drug formulation.
- •Current participation in another clinical study involving an experimental treatment or participation in such a study within 30 days prior to study entry.
- •Require concomitant use of TNF-blocking agents (e.g., Etanercept, Adalimumab, Infliximab).
- •Have a history of glaucoma or intraocular pressure (IOP) > 25 mmHg at the Visit 1A (Medical Screening) or a history of elevated IOP within the past year.
- •Have had ocular surgery including laser procedures within the past 12 months of Visit 1A (Medical Screening).
- •Have had contact lens wear within 4 weeks prior to Visit 1A (Medical Screening) or unwilling to discontinue wear during the study period
研究组 & 干预措施
Active Comparator EBI-005 5 mg/mL
Active Comparator
Administered 3 times per day
干预措施: Active Comparator EBI-005 5 mg/mL (Drug)
Placebo Comparator
Placebo Comparator
Administered 3 times per day
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
时间窗: 17 days
次要结局
- Evaluation of antibodies to EBI-005.(up to 45 days)
- Evaluation of ocular changes(up to 45 days)
- Evaluation of Adverse Events.(up to 45 days)
研究者
研究点 (1)
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