Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 415
- 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
This clinical study is being conducted to identify the most effective drug concentration and dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of inflammation 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 must be at least 18 years of age on the date the Informed Consent Form (ICF) is signed and with the capacity to voluntarily provide consent.
- •Subjects must be able to understand and provide written consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations.
- •Subjects who are candidates for cataract surgery.
- •Subjects who are not of childbearing potential or female subjects who have a negative urine pregnancy test result at screening.
- •Subjects must be able and willing to comply with all treatment and follow- up procedures.
排除标准
- •Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
- •Subjects who have a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result of the study.
- •Subjects who have a severe/serious ocular condition, or any other unstable medical condition that, in the Investigator's opinion, may preclude study treatment or follow-up.
研究组 & 干预措施
BOL-303242-X
BOL-303242-X (Mapracorat)
干预措施: BOL-303242-X (Drug)
Vehicle
Vehicle for BOL-303242-X (Mapracorat)
干预措施: Vehicle for BOL-303242-X (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 will be 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. Pigment cells and red blood cells are to be ignored. 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.
次要结局
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.(8 days)