Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Resolution of Anterior Chamber Cells (ACC).
研究概览
简要总结
This study is being conducted to compare the safety and efficacy of loteprednol etabonate compared to vehicle for the treatment of postoperative inflammation and pain following 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are at least 18 years of age.
- •Subjects who are candidates for routine, uncomplicated cataract surgery.
- •Subjects who, in the Investigator's opinion, have potential postoperative pinholed Snellen visual acuity (VA) of at least 20/200 in the study eye.
排除标准
- •Subjects who have known hypersensitivity or contraindication to the study drug or components.
- •Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
- •Subjects with elevated intraocular pressure (>/= 21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
- •Subjects who are monocular or have pinholed Snellen VA 20/200 or worse in the non-study eye.
研究组 & 干预措施
Loteprednol Etabonate
Loteprednol etabonate
干预措施: Loteprednol Etabonate (Drug)
Vehicle
Vehicle of loteprednol etabonate
干预措施: Vehicle of Loteprednol Etabonate (Drug)
结局指标
主要结局
Resolution of Anterior Chamber Cells (ACC).
时间窗: Visit 5 (Postoperative day 8)
Number of Study eyes with complete resolution(Grade 0) of anterior chamber cells (ACC) for loteprednol and vehicle. Accumulation of white cells in aqueous graded on a scale of 0-4 where grade 0=no cells. Investigators assessed ACC using a slit lamp.
Grade 0 Pain
时间窗: Visit 5 (Postoperative Day 8)
Number of eyes with grade 0 ocular pain. Ocular pain, defined as a positive sensation of the eye, based on a 0-5 scale where grade 0 equaled no pain and grade 5 equaled severe pain. Ocular pain graded by participants.
次要结局
- Resolution of Anterior Chamber Cells.(At visits 4-7- postoperative day 3, 8,15 & 18)