A Randomized, Double-masked, Active-controlled, Multi-center Phase 2 Clinical Study Evaluating the Efficacy and Safety of 0.5% and 1.0% VVN461 Ophthalmic Solution in Patients With Noninfectious Anterior Uveitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- ACC score of ≥2 grade from baseline at Day 14
研究概览
简要总结
This is a multicenter, double-masked, randomized, active-controlled, parallel-comparison study conducted at sites in the China in subjects with Noninfectious Anterior Uveitis
详细描述
In this study, subjects who meet the inclusion/exclusion criteria will be randomized to receive one of the three treatments prednisolone acetate during the Screening/Baseline Visit (Day-2 to Day 1). Starting from Visit 1 (Day 1), subjects will be administered one drop of the investigational product in the study eye in following dose regimens: 6 times per day (Q2h, 2 hours apart) for 7 days; 4 times per day (QID) for 7 days；2 times per day (BID) for 7 days；once a day (QD) for 7 days. Subjects will return to clinic for study assessments on Day 3 (Visit 2), Day 7 (Visit 3), Day 14 (Visit 4), Day 21 (Visit 5) and Day 28 (Visit 6, end of study) or early withdrawal/termination visit.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-70 years at the time providing signed informed consent
- •At least 1 eye diagnosed with noninfectious anterior uveitis at the time of screening
- •Willing and able to comply with study requirements and visit schedule
排除标准
- •Diagnosis of intermediate uveitis, posterior uveitis or panuveitis in either eye at the time of screening
研究组 & 干预措施
VVN461, 1.0%
VVN461 Ophthalmic Solution, 1.0%
干预措施: VVN461 Ophthalmic Solution 1.0% (Drug)
VVN461, 0.5%
VVN461 Ophthalmic Solution, 0.5%
干预措施: VVN461 Ophthalmic Solution 0.5% (Drug)
Prednisolone acetate, 1%
Prednisolone acetate Ophthalmic Solution, 1%
干预措施: Prednisolone acetate (Drug)
结局指标
主要结局
ACC score of ≥2 grade from baseline at Day 14
时间窗: Day 14
Proportion of subjects with improvement in ACC score of ≥2 grade from baseline at Day 14
次要结局
- ACC score of 0(Baseline to Day 28)