Evaluation of Safety and Tolerability of Investigational Ocular Lubricants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 3
- 主要终点
- Best corrected visual acuity (BCVA) with manifest refraction, at distance
研究概览
简要总结
The purpose of this study is to evaluate investigational ocular lubricants for their safety and tolerability on subjects with mild to moderate dry eye disease.
详细描述
Subjects will be expected to attend a screening visit followed by 6 additional study visits. The expected duration of subject participation is approximately 3 weeks. This study will be conducted in Australia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Sign an Informed Consent;
- •Have dry eye symptoms;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Ocular abnormalities;
- •Active ocular infection or inflammation not associated with dry eye;
- •History of ocular or intraocular surgery;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
FID123300/FID123301/FID122505
FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID123300 ocular lubricant (Other)
FID123300/FID123301/FID122505
FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID123301 ocular lubricant (Other)
FID123300/FID123301/FID122505
FID123300 ocular lubricant in Period 1, followed by FID12330 ocular lubricant in Period 2, followed by FID122505 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID122505 ocular lubricant (Other)
FID123301/FID122505/FID123300
FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID123300 ocular lubricant (Other)
FID123301/FID122505/FID123300
FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID123301 ocular lubricant (Other)
FID123301/FID122505/FID123300
FID123301 ocular lubricant in Period 1, followed by FID122505 ocular lubricant in Period 2, followed by FID123300 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID122505 ocular lubricant (Other)
FID122505/FID123300/FID123301
FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID123300 ocular lubricant (Other)
FID122505/FID123300/FID123301
FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID123301 ocular lubricant (Other)
FID122505/FID123300/FID123301
FID122505 ocular lubricant in Period 1, followed by FID123300 ocular lubricant in Period 2, followed by FID123301 ocular lubricant in Period 3, as randomized. For each period, the subject will receive one drop in each eye for one day. A 1-4 day washout will separate each period.
干预措施: FID122505 ocular lubricant (Other)
结局指标
主要结局
Best corrected visual acuity (BCVA) with manifest refraction, at distance
时间窗: Day 1, each wear period. A wear period is 1 day.
BCVA will be collected for each eye individually and recorded in logarithm Minimum Angle of Resolution (logMAR)
次要结局
未报告次要终点