NCT00825721Unknown2 期
A Randomized, Placebo-Controlled, Single-Masked, Dose-Ranging Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear Cataracts
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Best-corrected visual acuity by ETDRS
研究概览
简要总结
This study will evaluate the safety and efficacy of three doses of C-KAD Ophthalmic Solution in patients with loss of visual function due to age-related nuclear cataract
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
- 35 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of nuclear sclerosis cataract
- •BCDVA within the range of 20/40 and 20/80
排除标准
- •Any other clinical condition in the eye that may compromise vision
- •Presence or history of glaucoma
- •Presence or history of diabetes
- •Use of eyedrops
- •Use of steroids
研究组 & 干预措施
1.3% (low dose)
Active Comparator
干预措施: C-KAD Ophthalmic Solution (Drug)
2% (medium dose)
Active Comparator
干预措施: C-KAD Ophthalmic Solution (Drug)
2.6% (high dose)
Active Comparator
干预措施: C-KAD Ophthalmic Solution (Drug)
Placebo
Placebo Comparator
干预措施: LiquiTears (Drug)
结局指标
主要结局
Best-corrected visual acuity by ETDRS
时间窗: 360 days
次要结局
未报告次要终点
研究者
研究点 (1)
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