NCT01048593终止2 期
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Cataract Surgery Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Clearance of Anterior Chamber Cells
研究概览
简要总结
This study will test the efficacy and safety of IBI-10090 for the reduction of ocular inflammation after cataract surgery.
详细描述
All patients received active treatment in this study. Dose group 1 received 114ug of dexamethasone, Dose group 2 received 513ug and Dose group 3 received 684ug.
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)
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 patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.
排除标准
- •Patients who have used any ocular, topical or oral corticosteroids within 7 days prior to Day
- •Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
- •Patients with any signs of intraocular inflammation in either eye at screening.
- •Patients who have received any prior intravitreal injections in the study eye.
研究组 & 干预措施
Dose 1
Experimental
114ug
干预措施: IBI-10090 (Drug)
Dose 2
Experimental
513ug
干预措施: IBI-10090 (Drug)
Dose 3
Experimental
684ug
干预措施: IBI-10090 (Drug)
结局指标
主要结局
Clearance of Anterior Chamber Cells
时间窗: Day 8 post treatment
Efficacy was assessed by slit lamp biomicroscopy to evaluate the anterior chamber cells (ACC) graded on a scale of 0 to 4. The primary efficacy endpoint was complete clearing of ACC, where grade 0 = 0 cells in the anterior chamber on POD 8.
次要结局
- Anterior Chamber Flare (ACF) Grade(Day 90 post-treatment)
- Anterior Chamber Cell Grade(Day 90 post-treatment)
- Conjunctival Erythema Grade(Day 90 post-treatment)
- Corneal Edema Grade(Day 90 post-treatment)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Efficacy and Safety Study of IBI-10090 in Cataract Surgery PatientsOcular InflammationNCT01214174ICON Bioscience Inc42
已完成
2 期
Efficacy and Safety of IBI-10090 in Ocular Surgery PatientsInflammation Associated With Cataract SurgeryNCT01606735ICON Bioscience Inc172
已完成
3 期
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye DiseaseDry Eye DiseaseNCT00404131Merck Sharp & Dohme LLC500
已完成
3 期
Study of INS365 Ophthalmic Solution in Subjects With Dry Eye DiseaseDry Eye DiseaseNCT00403715Merck Sharp & Dohme LLC500
已完成
2 期
Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery SubjectsPost-surgical Ocular InflammationPost-surgical Ocular PainNCT04324359Surface Ophthalmics, Inc.91