A Phase 3, Prospective, Randomized, Parallel-design, Multicenter Study to Evaluate the Safety of Icon Bioscience-10090 for the Treatment of Inflammation Associated With Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 194
- 试验地点
- 10
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
研究概览
简要总结
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups
- A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
- Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
详细描述
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups
- A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
- Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing cataract surgery
排除标准
- •glaucoma patient, pregnancy, allergy to dexamethasone
研究组 & 干预措施
dexamethasone depot
dexamethasone depot 517 mcg
干预措施: Dexamethasone (Drug)
standard of care
prednisolone drops 1%
干预措施: Prednisolone (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
时间窗: Baseline to postoperative day 90/ early termination
Treatment-emergent Adverse Events were defined as events that started after the study drug administration, and occurred before termination of the study, or were present before study drug administration and worsened after dose administration.
次要结局
- Intraocular Pressure Measurement(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
- Visual Acuity in Study Eye(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
- Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
- Slit Lamp Biomicroscopy - Cornea Edema Grade(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
- Summary of Concomitant Medications Used in the Study Eye or Both Eyes(Baseline, Postoperative (POD) 1, POD 8, POD 30, POD 90/Early termination)
- Changes in the Corneal Endothelial Cell Count(Baseline, Postoperative day 90/Early termination)
- Optic Disc Cup-disc Ratio for the Study Eye(Baseline, POD 90/Early termination)
- Dilated Opthalmoscopy Findings - Optic Disc (Study Eye)(Baseline, POD 90/Early termination)
- Dilated Opthalmoscopy Findings - Retina (Study Eye)(Baseline, POD 90/Early termination)
- Dilated Opthalmoscopy Findings - Macula (Study Eye)(Baseline, POD 90/Early termination)
- Dilated Opthalmoscopy Findings - Choroid (Study Eye)(Baseline, POD 90/Early termination)
- Dilated Opthalmoscopy Findings - Vitreous (Study Eye)(Baseline, POD 90/Early termination)