NCT01736462已完成1 期
An Open-Label Study to Evaluate 3 Month Corneal Endothelial Cell Density Changes in Healthy Subjects When Mapracorat Ophthalmic Suspension, 3%, is Administered 4 Times Daily for 14 Days
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Endothelial Cell Density
研究概览
简要总结
The objective of this study is to evaluate the effect on corneal endothelial cell density (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered QID (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a Pinhole visual acuity (VA) equal to or better than 20/40 in both eyes.
- •Must be in good ocular health
排除标准
- •Subjects who have known hypersensitivity or contraindication to the study drug or its 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.
- •Any topical ophthalmic medication, including tear substitutes that cannot be discontinued during the study.
- •Subjects who are monocular (fellow eye is absent or fellow eye's Pinhole VA is worse than 20/200).
- •Subjects with a history of ocular surgery, or who anticipate ocular surgery in either eye within the study period.
- •Presence of significant ocular or systemic disease that the Investigator determines could interfere with the study.
研究组 & 干预措施
Mapracorat
Experimental
Mapracorat ophthalmic suspension, 3%
干预措施: Mapracorat (Drug)
结局指标
主要结局
Endothelial Cell Density
时间窗: 3 months (Visit 4)
The mean endothelial cell density (cells/mm2)(ECD)
次要结局
- Area under the plasma concentration-time curve(Day 15 (Visit 3))
研究者
研究点 (1)
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