NCT01060072已完成3 期
A Randomized, Multicenter, Double-Masked, Parallel-Group Clinical Safety and Efficacy Evaluation of Loteprednol Etabonate, 0.5% Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 407
- 试验地点
- 1
- 主要终点
- Resolution of Anterior Chamber Cells.
研究概览
简要总结
This study is being conducted to compare the safety and efficacy of loteprednol etabonate 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.
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 visual acuity (VA) 20/200 or worse in the non-study eye.
研究组 & 干预措施
Loteprednol etabonate
Experimental
Loteprednol etabonate 0.5% ophthalmic suspension
干预措施: Loteprednol etabonate (Drug)
Vehicle
Placebo Comparator
Vehicle of loteprednol etabonate ophthalmic suspension
干预措施: Vehicle of Loteprednol Etabonate (Drug)
结局指标
主要结局
Resolution of Anterior Chamber Cells.
时间窗: Visit 5 (Postoperative day 8)
Participants with complete resolution of anterior chamber cells(ACC). Cells were graded on a 0-4 scale, where 0=no cells and 4=\>30 cells
Grade 0 Pain
时间窗: Visit 5 (Postoperative day 8)
Participants with no pain, graded on a 0-5 scale, 0=no pain and 5=severe pain
次要结局
- Resolution of Anterior Chamber Cells(Visit 4-7 (postoperative day 3-18))
- Grade 0 Pain(Visits 4-7 (Postoperative days 3-18))
- Resolution of Anterior Chamber Flare(Visit 4-7 (postoperative day 3-18))
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract SurgeryInflammationPainNCT01010633Bausch & Lomb Incorporated406
已完成
1 期
Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract SurgeryInflammation Following Ocular SurgeryNCT03531697Sandoz381
已完成
3 期
MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)HypercholesterolemiaNCT00092690Organon and Co1,902
已完成
2 期
A Study in Subjects With Perennial Allergic RhinitisPerennial Allergic RhinitisNCT00210015Merck Sharp & Dohme LLC630
已完成
3 期
Effectiveness of Two Approved Drugs in Lowering High Cholesterol (0733-224)HypercholesterolemiaNCT00092157Organon and Co571