NCT05550363撤回3 期
A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
研究概览
简要总结
A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with Cataract Surgery
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects at least 40 years of age scheduled for cataract surgery
- •Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
- •Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.
排除标准
- •Use of any corticosteroids within 7 days prior to Day 0
- •Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
- •Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.
研究组 & 干预措施
DEXYCU
Experimental
DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg
干预措施: Dexycu (Drug)
Placebo
Placebo Comparator
Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg
干预措施: Placebo/Vehicle (Other)
结局指标
主要结局
Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8
时间窗: Day 8
次要结局
- Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30(Days 1, 3, 15, and 30)
- Mean ocular pain scores in the study eye(Days 1, 3, 15, and 30)
- Mean AC cell score in the study eye(Days 1, 3, 15, and 30)
- Proportion of subjects with absence of cells in the AC of the study eye(Days 1, 3, 15, and 30)
- Mean AC flare score in the study eye(Days 1, 3, 15, and 30)
- Rates of ocular (study eye and fellow eye) and non-ocular TEAEs(up to day 30)
- Proportion of subjects with absence of flare in the AC of the study eye(Days 1, 3, 15, and 30)
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