NCT05456425进行中（未招募）3 期
Multicenter, Double-Masked, Randomized, Vehicle-Controlled 12-Month Parallel Comparison of the Safety and Efficacy of 0.1% and 0.2% CBT-001 Versus Vehicle, Dosed Twice-Daily, in Patients With Pterygium
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 660
- 试验地点
- 44
- 主要终点
- pterygium length
研究概览
简要总结
The objective is to evaluate the safety and efficacy of low dose and high dose CBT-001 eye drop dosed twice daily for 24 months compared to vehicle in reducing conjunctival hyperemia and preventing pterygium progression in eyes with pterygia.
详细描述
Clinical Hypotheses:
- CBT-001 dosed twice daily is more effective than vehicle in:
- Reducing conjunctival hyperemia by demonstrating a statistically significant difference and clinically relevant improvement in the mean severity grade change from baseline.
- Preventing pterygium progression, by demonstrating a statistically significant and clinically relevant improvement on drug vs vehicle mean difference in the change in pterygium length from baseline.
- CBT-001 dosed twice daily maintains the above efficacies and has an acceptable ocular and systemic safety and tolerability profile when administered topically.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pterygium with conjunctival hyperemia
排除标准
- •Pterygium removal within the last 6 months
研究组 & 干预措施
CBT-001 High Dose
Experimental
CBT-001 eye drop
干预措施: CBT-001 (Drug)
Vehicle
Placebo Comparator
Emulsion eye drop without drug
干预措施: Vehicle (Drug)
CBT-001 Low Dose
Experimental
CBT-001 eye drop
干预措施: CBT-001 (Drug)
结局指标
主要结局
pterygium length
时间窗: 12 month
Mean difference of pterygium lesion length change from baseline.
conjunctival hyperemia
时间窗: 3 month
Mean difference of conjunctival hyperemia grade change from baseline.
次要结局
未报告次要终点
研究者
研究点 (44)
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