NCT05191706招募中4 期
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Grade of anterior chamber cells (ACC)
研究概览
简要总结
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood 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
- None
入排标准
- 年龄范围
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
- •If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.
- •Has a post-traumatic cataract.
- •Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
- •Ocular hypertension with an IOP in the study eye >25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
- •Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
- •Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.
- •Other protocol-specified exclusion criteria may apply
研究组 & 干预措施
DEXYCU (dexamethasoneintraocular suspension) 9%
Experimental
A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
干预措施: Dexamethasone (Drug)
Prednisolone acetate ophthalmic suspension (USP) 1%
Active Comparator
Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion.
干预措施: Prednisolone Acetate Ophthalmic (Drug)
结局指标
主要结局
Grade of anterior chamber cells (ACC)
时间窗: Post-Operative Day 14
次要结局
- Grade of anterior chamber flare (ACF)(Post-Operative Day 14)
研究者
研究点 (2)
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