A Randomized, Parallel-Arm, Active Control, Multi-Center Study Assessing the Safety And Efficacy Of Dextenza® for the Treatment Of Ocular Pain and Inflammation Following Surgery for Pediatric Cataract
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
To assess the safety of Dextenza compared to an active control, prednisolone acetate suspension, for the treatment of postoperative pain and inflammation following ocular surgery for pediatric cataract.
详细描述
Randomized, parallel-arm, active control, multi-center study assessing the safety of Dextenza for the treatment of ocular pain and inflammation following surgery for pediatric cataract. The subjects will be followed for approximately 2-3 months from screening to the last visit.
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
- 0 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is 0-5 years of age (up to the day before the subject turns 6 years of age). In the event that a subject aged 0-5 years enrolls in the study and then undergoes a second cataract surgery in the contralateral eye during the study period, the subject remains eligible for participation for both eyes, regardless if the second surgery occurs when the subject is >5 years of age)
- •Has a cataract and is expected to undergo primary cataract surgery with or without implantation of a posterior chamber intraocular lens
排除标准
- •Any intraocular inflammation in the study eye present during the screening slit lamp examination
- •Has ocular hypertension (defined as IOP of >21 mmHg), or glaucoma or is on medications to treat ocular hypertension or glaucoma or has a history of IOP spikes in either eye including steroid-related IOP increases
- •Evidence of acute external ocular infections (bacterial, viral and/or fungal such as vaccinia, varicella, and other viral diseases of the cornea and conjunctiva), tuberculosis of the eye; corneal dystrophies; active corneal ulcers, intraocular infections, dysthyroid ophthalmopathy, active chalazion, or uncontrolled blepharitis in the study eye
研究组 & 干预措施
Dextenza
1 dosing group - 37 eyes treated with Dextenza
干预措施: Dextenza Ophthalmic Insert (Drug)
Prednisolone
1 dosing group - 32 eyes treated with Prednisolone
干预措施: Prednisolone acetate ophthalmic suspension USP 1% (Drug)
结局指标
主要结局
Adverse Events
时间窗: Up to approximately 42 days after surgery
Number of Ocular Treatment Emergent Adverse Events (TEAEs) and Non-ocular Treatment Emergent Adverse Events (TEAEs)
Subject FLACC Pain Assessment
时间窗: From screening through day 42
Behavioral Observation Pain Rating Scale from 0 (no pain) to 10 (most pain).
IOP
时间窗: From screening, then day 2 through 42
IOP measured in units of mmHg.
次要结局
未报告次要终点