NCT05234554已完成3 期
The INVIGORATE 2 Trial: A Single-center, Randomized, Double-masked, Crossover Design, Vehicle-controlled, Phase 3 Clinical Trial to Assess the Efficacy and Safety of Reproxalap Ophthalmic Solution (0.25%) Compared to Vehicle in Subjects With Seasonal Allergic Conjunctivitis Using the Environmental Exposure Chamber (EEC)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 131
- 试验地点
- 1
- 主要终点
- Ocular itching evaluated by the Subject.
研究概览
简要总结
The INVIGORATE 2 Trial: A single-center, randomized, double-masked, crossover design, vehicle-controlled, Phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (EEC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Be at least 18 years of age at the time of screening of either sex or any race;
- •Provide written informed consent;
- •Be willing and able to follow instructions, and can attend all required clinical trial visits.
- •Have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement;
- •Have a positive skin prick test to ragweed pollen within the past year of the Medical Screening Visit (Visit 1).
排除标准
- •Have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis;
- •Have systemic signs of infection (e.g., fever, current treatment with antibiotics).
- •Have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. Such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease;
- •Be a WOCBP who is pregnant, nursing, or not using an effective means of contraception;
- •Have any known contraindication or hypersensitivities to any components of the Investigational Product (IP) drug formulation.
研究组 & 干预措施
Reproxalap Ophthalmic Solution (0.25%)
Experimental
干预措施: Reproxalap Ophthalmic Solution (0.25%) (Drug)
Vehicle Ophthalmic Solution
Placebo Comparator
干预措施: Vehicle Ophthalmic Solution (Drug)
结局指标
主要结局
Ocular itching evaluated by the Subject.
时间窗: During EEC allergen exposure.
The method of assessment for the primary outcome is a 9-point ocular itch scale (0 none - 4 severe).
次要结局
- Conjunctival redness evaluated by the Subject.(During EEC allergen exposure.)
研究者
研究点 (1)
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