A Multi-Center, Randomized, Double-Masked Evaluation of the Efficacy of Administration of FOV1101-00 (Cyclosporine Low Dose and High Dose) and Prednisolone Acetate Compared to Its Components and Vehicle 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
- 716
- 试验地点
- 1
- 主要终点
- Diary assessment of signs and symptoms of ocular allergy
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of the administration of cyclosporine and prednisolone acetate compared to placebo in the treatment of allergic conjunctivitis.
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
- 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
- •history of ocular allergies and a positive skin test reaction to perennial allergens within the past 24 months and a history of chronic eye irritation
- •visual acuity score ≥ 0.60 (EDTS)
- •negative urine pregnancy test for female patients, and use of adequate birth control throughout the study period.
排除标准
- •active ocular infection; preauricular lymphadenopathy or ocular condition that could affect study; glaucoma or abnormal intraocular pressure; ocular surgery within past 3 months; history of asthma, pregnancy or nursing
- •contraindications or known allergies to the study drug(s)
研究组 & 干预措施
Cyclosporine low dose , Prednisolone Acetate
Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
干预措施: CsA low dose (Drug)
Cyclosporine low dose , Prednisolone Acetate
Administration of a solution of Cyclosporine (low dose) and a suspension of Prednisolone Acetate
干预措施: PA (Drug)
Cyclosporine high dose, Prednisolone Acetate
Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
干预措施: CsA high dose (Drug)
Cyclosporine high dose, Prednisolone Acetate
Administration of a solution of Cyclosporine (high dose) and a suspension of Prednisolone Acetate
干预措施: PA (Drug)
Cyclosporine high dose
Administration of a solution of Cyclosporine (high dose) and Placebo
干预措施: CsA high dose (Drug)
Cyclosporine high dose
Administration of a solution of Cyclosporine (high dose) and Placebo
干预措施: Placebo (Drug)
Cyclosporine low dose
Administration of a solution of Cyclosporine (low dose) and Placebo
干预措施: CsA low dose (Drug)
Cyclosporine low dose
Administration of a solution of Cyclosporine (low dose) and Placebo
干预措施: Placebo (Drug)
Prednisolone Acetate
Administration of a suspension of Prednisolone Acetate and Placebo
干预措施: PA (Drug)
Placebo
Administration of Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Diary assessment of signs and symptoms of ocular allergy
时间窗: During the 28 days of treatment
Patient-reported ocular itching and redness
次要结局
- Diary and office assessments of various ocular and nasal allergy signs and symptoms(During 28 days of treatment)
- Safety(During the 28 days of treatment)