Study to Assess 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
- 已完成
- 入组人数
- 311
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Grade 0 Pain
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% 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
- •Participants who are candidates for routine, uncomplicated cataract surgery
- •Participants who, in the Investigator's opinion, have potential postoperative pinhole Snellen visual acuity (VA) of at least 20/200 in the study eye.
- •Participants must be willing to wait to undergo cataract surgery on the fellow eye until after the study has been completed.
排除标准
- •Participants who are expected to require concurrent ocular therapy (either eye) with nonsteroidal anti-inflammatory drugs (NSAIDs), mast cell stabilizers, antihistamines, or decongestants.
- •Participants who are expected to require treatment with any systemic or ocular (either eye) corticosteroids or glucocorticoids.
- •Participants who are expected to require concurrent ocular therapy with immunosuppressants (eg, Restasis).
- •Participants who have known hypersensitivity or contraindication to the study drug(s) or their components.
- •Participants participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or during the period of study participation.
研究组 & 干预措施
Vehicle
Vehicle of mapracorat ophthalmic suspension
干预措施: Vehicle (Drug)
Mapracorat
Ophthalmic suspension 3%
干预措施: Mapracorat (Drug)
结局指标
主要结局
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, were higher scores indicated worse pain.
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.
次要结局
- Percentage of Participants With Complete Resolution of Anterior Chamber (AC) Flare.(8 days)