Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Subjects 18 years of age or older
排除标准
- •No active ocular conditions of disease
研究组 & 干预措施
bromfenac ophthalmic solution 0.06%
bromfenac ophthalmic solution 0.06% bilaterally twice a day
干预措施: bromfenac ophthalmic solution 0.06% (Drug)
结局指标
主要结局
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
时间窗: Baseline, Day 42
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria.
Percentage of Participants With at Least One Adverse Event
时间窗: 52 days
次要结局
- Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye(Baseline, 42 days)