Safety and Tolerability of Artificial Tears in Dry Eye Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 47
- 主要终点
- Tolerability Questionnaire Mean Scores at 1 Week
研究概览
简要总结
The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Mild, moderate or severe symptoms of dry eye
排除标准
- •Uncontrolled systemic disease
- •Contact lens wear
- •Participation in another clinical study
研究组 & 干预措施
Glycerin and Polysorbate 80 based artificial tear
Glycerin and Polysorbate 80 based artificial tear
干预措施: Glycerin and Polysorbate 80 based artificial tear (Drug)
结局指标
主要结局
Tolerability Questionnaire Mean Scores at 1 Week
时间窗: 1 Week
Tolerability Questionnaire mean scores at 1 week. The Tolerability Questionnaire includes 8 tolerability questions on selected performance measures. All questions are scored based on continuous visual analog scale from 0-100. The first 4 questions presented measure increasing tolerability where 0=worst and 100=best. The second set of 4 questions presented measure decreasing tolerability where 0=best and 100=worst.
次要结局
- Number of Patients With at Least One Severity Grade Increase in Biomicroscopy Findings at 1 Week(1 Week)
- Best-Corrected Visual Acuity (BCVA) Status at 1 Week(1 Week)
- The Number of Ophthalmic Adverse Events at 1 Week(1 Week)