The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation Following Cataract Surgery
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
研究概览
简要总结
The objective of this study is to compare the safety and efficacy of Mapracorat Ophthalmic Suspension, 3% 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 candidates for routine, uncomplicated cataract surgery.
- •Subjects must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.
排除标准
- •Subjects who are expected to require treatment with any systemic or ocular (either eye) drugs specified in the protocol during the 18 days following cataract surgery or any systemic or ocular corticosteroids within 14 days prior to cataract surgery.
- •Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
- •Subjects who have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
研究组 & 干预措施
Mapracorat
Mapracorat ophthalmic suspension
干预措施: Mapracorat (Drug)
Vehicle
Vehicle of mapracorat ophthalmic suspension
干预措施: Vehicle (Drug)
结局指标
主要结局
Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.
时间窗: 8 days
Anterior chamber (AC) cells were assessed using a 0 to 4 grading scale by an ophthalmologist using slip lamp biomicroscopy. A slit lamp examination of the lids, conjunctiva, limbus, cornea, anterior chamber, vitreous, and lens was performed without pupil dilation. Accumulation of white blood cells in aqueous was assessed. The grades were defined as: 0 = No cells seen; 1 = 1 - 5 cells; 2 = 6 - 15 cells; 3 = 16 - 30 cells; 4 = \>30 cells. Complete resolution of AC cells was defined as Grade 0.
Percentage of Participants With Grade 0 Pain
时间窗: 8 days
Ocular pain was defined as a positive sensation of the eye, including foreign body sensation, stabbing, throbbing, or aching. The scores ranged from 0=None to 5=Severe, where higher scores indicated worse pain.
次要结局
未报告次要终点