The Efficacy and Safety of Mapracorat Ophthalmic Suspension, 3% in Subjects for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 360
- 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 clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.
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 who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
- •Subjects who have ≥ Grade 2 (6 - 15 cells) AC cells in the study eye following cataract surgery (postoperative day 1).
排除标准
- •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.
- •Any intraocular inflammation in either eye (cells or flare score greater than Grade 0 at slit lamp examination) or ocular pain greater than Grade 1 in the study eye at the Screening Visit.
- •Presence of active external ocular disease: infection or inflammation of the study eye.
- •Subjects who have known hypersensitivity or contraindication to the study drug(s) or their components.
- •Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
研究组 & 干预措施
Mapracorat
Mapracorat ophthalmic suspension, 3%,
干预措施: Mapracorat (Drug)
Vehicle
The vehicle of the 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
- Percentage of Participants With Grade 0 Pain(15 days)
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells.(15 days)
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.(15 days)
- Percentage of Treatment Failures(8 days)
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Cells and Flare.(15 days)