NCT01289431已完成2 期
Dose Ranging Study to Evaluate the Safety and Efficacy of Mapracorat Ophthalmic Formulation, in Subjects With Allergic Conjunctivitis Compared to Vehicle in a Conjunctival Allergen Challenge (CAC).
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Conjunctival Redness
研究概览
简要总结
The objective of this study is to evaluate the dose response, and efficacy of Mapracorat ophthalmic formulation compared to its vehicle for the prevention of symptoms and signs associated with allergic conjunctivitis using a conjunctival allergen challenge (CAC) model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •positive history of ocular allergies and a positive skin test reaction
- •positive bilateral CAC reaction
排除标准
- •have known contraindications or sensitivities to the use of any of the study medications(s) or their components.
- •have any ocular condition or significant illness that, in the opinion of the investigator, could affect the subject's safety or trial parameters.
- •had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 3 months;
- •a known history of retinal detachment, diabetic retinopathy, or active retinal disease;
- •the presence of an active ocular infection or positive history of an ocular herpetic infection at any visit.
- •use of any disallowed medications during the period indicated prior to Visit 1 and during the study.
- •have planned surgery during the trial period or within 30 days after.
- •have an intraocular pressure that is less than 5 mmHg or greater than 22 mmHg or any type of glaucoma at Visit 1
研究组 & 干预措施
Mapracorat
Experimental
干预措施: Mapracorat (Drug)
Mapracorat Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Conjunctival Redness
时间窗: 8 hours
Conjunctival redness was assessed by the Investigator on a 0-4 scale with half unit increments allowed. Lower scores indicate less conjunctival redness.
Ocular Itching
时间窗: 8 hours
Ocular itching was assessed by the participant on a 0-4 scale with half unit increments allowed. Lower scores indicate less ocular itching.
次要结局
- Ciliary Redness(8 hours)
- Episcleral Redness(8 hours)
研究者
研究点 (1)
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