A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Co-Administration of FOV1101-00 (Cyclosporine 0.01% or 0.02%) and Prednisolone Acetate 0.12% (PredMild®) Compared to Prednisolone Acetate 1% Alone or Vehicle Alone in Patients With Mild Ongoing Ocular Allergic Inflammation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Ocular Allergic signs and symptoms Diary Scores
研究概览
简要总结
This is a phase 2 study that will consist of 3 visits during a 3 week period conducted at up to 5 sites. The purpose of this study is to determine how effective the combination of Pred Mild® and FOV1101-00 is compared to either Pred Forte® alone or to vehicle alone in the prevention of eye allergies. Study subjects will be randomized to one of the following:
- FOV1101-00 concentration 1 and Pred Mild®
- FOV1101-00 concentration 2 and Pred Mild®
- Vehicle of FOV1101-00 and Pred Forte®
- Vehicle of FOV1101-00 and Vehicle of FOV1101-00
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 是
入选标准
- •history of ocular allergies and a positive skin test reaction to allergens within the past 24 months and a history of chronic eye irritation;
排除标准
- •active ocular infection; clinically significant blepharitis; follicular conjunctivitis; iritis; any type of glaucoma; ocular surgery within past 3 months; pregnancy or nursing
研究组 & 干预措施
1
FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)
干预措施: Prednisolone Acetate 0.12% (Pred Mild®) (Drug)
1
FOV1101-00 concentration 1 and Prednisolone Acetate 0.12% (Pred Mild®)
干预措施: FOV1101-00 (Drug)
2
FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)
干预措施: Prednisolone Acetate 0.12% (Pred Mild®) (Drug)
2
FOV1101-00 concentration 2 and Prednisolone Acetate 0.12% (Pred Mild®)
干预措施: FOV1101-00 (Drug)
3
Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)
干预措施: Prednisolone Acetate 1% (Pred Forte®) (Drug)
3
Vehicle of FOV1101-00 and Prednisolone Acetate 1% (Pred Forte®)
干预措施: Placebo (Drug)
4
Vehicle of FOV1101-00 and vehicle of FOV1101-00
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Allergic signs and symptoms Diary Scores
时间窗: Between V2 and V3
次要结局
- Various ocular and nasal allergic diary scores(Between V2 and V3)