NCT00793091Unknown2 期
A Phase 2, Randomized, Placebo-Controlled, Double-Masked, Multicenter Safety and Efficacy Study of C-KAD Ophthalmic Solution in Patients With Loss of Visual Acuity Due to Age-Related Cataract
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Best-corrected visual acuity by ETDRS
研究概览
简要总结
The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related 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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of age-related cataract in the study eye
- •Best-corrected visual acuity of 20/25 to 20/50 in the study eye
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
Active Comparator
干预措施: C-KAD Ophthalmic Solution (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Best-corrected visual acuity by ETDRS
时间窗: 120 Days
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
2 期
Dose-Ranging Study of an Ophthalamic Solution in Patients With Loss of Visual Function Due to Age-Related Nuclear CataractNuclear CataractNCT00825721Chakshu Research, Inc.81
已完成
不适用
An Open-Label Study of an Ophthalmic Solution to Reduce Intraocular Pressure in Patients With Ocular HypertensionOcular HypertensionNCT00825396Chakshu Research, Inc.12
已完成
2 期
Safety and Efficacy of KPI-121 in Subjects With Dry Eye DiseaseDry Eye SyndromesKeratoconjunctivitis SiccaNCT02188160Kala Pharmaceuticals, Inc.150
Unknown
2 期
An Open-Label Study of the Effect of an Ophthalmic Solution on Asteroid HyalosisAsteroid HyalosisNCT00825942Chakshu Research, Inc.20
已完成
3 期
Study Evaluating the Safety of KetoNaph Ophthalmic Solution in Healthy VolunteersAllergic ConjunctivitisNCT01159015Bausch & Lomb Incorporated534