A Multi-Center, Double-Masked, Vehicle-Controlled, Evaluation of the Efficacy and Safety of CSF-1 in the Temporary Correction of Presbyopia (the NEAR-2 Study: Near Eye-vision Acuity Restoration)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 1
- 主要终点
- Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.
研究概览
简要总结
This is a 4-visit, multi-center, randomized, double-masked, vehicle-controlled study evaluating the safety and efficacy of CSF-1 in the temporary correction of presbyopia.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 45 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have presbyopia.
排除标准
- •Subjects must not:
- •Have any contraindications to the study medications or diagnoses that would confound the study.
研究组 & 干预措施
CSF-1
One drop bilaterally twice daily for approximately 2 weeks.
干预措施: CSF-1 (Drug)
Vehicle
One drop bilaterally twice daily for approximately 2 weeks.
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of Subjects With a ≥ 3-line Gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8, 1 Hour Post-Dose 1.
时间窗: Baseline (Day 1) to Day 8 (1 hour post-Dose 1)
The primary end-point was measured on Day 8, 1 hour post first CSF-1 dose, as the number of participants who are responders to the treatment. A responder was defined as as subject with a ≥ 3-line gain in BDCVA (Best Distance-Corrected Visual Acuity) at 40cm and no loss in BDCVA ≥ 5 letters at 4m.
次要结局
- Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m.(Baseline (Day 1) to Day 8 (2 hours post-Dose 1))
- Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 1 Hour Post-Dose 2(Baseline (Day 1) to Day 8 (1 hour post Dose 2; Dose 2 occurred 2 hours following Dose 1))
- Percentage of Subjects With a ≥ 3-line Gain in BDCVA at 40cm and no Loss in BDCVA ≥ 5 Letters at 4m on Day 8 at 2 Hours Post-dose 2(Baseline (Day 1) to Day 8 (2 hours post Dose 2; Dose 2 occurred 2 hours following Dose 1))