Evaluation of Comfort of Ocular Lubricants in Symptomatic Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Ocular comfort
研究概览
简要总结
The purpose of this study is to evaluate the ocular comfort of 3 ocular lubricants and a comparator.
详细描述
The expected duration of subject participation is at least 7 days. This study will be conducted in Australia and Canada.
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
- 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
- •Is able to understand and sign an approved information consent letter;
- •Habitually wears daily disposable soft contact lenses in both eyes
- •Uses rewetting drops on a regular basis;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Routinely sleeps in habitual contact lenses;
- •Has any known active ocular disease and/or infection;
- •Is pregnant or lactating;
- •Other protocol specified exclusion criteria may apply.
研究组 & 干预措施
OTF Test 2
One application of ocular lubricant to each eye at night for 5 consecutive nights
干预措施: OTF Ocular Lubricant (Other)
OTF Test 1
One application of ocular lubricant to each eye at night for 5 consecutive nights
干预措施: OTF Ocular Lubricant (Other)
OTF Test 3
One application of ocular lubricant to each eye at night for 5 consecutive nights
干预措施: OTF Ocular Lubricant (Other)
Ocular lubricant
One drop of ocular lubricant applied to each eye at night for 5 consecutive nights
干预措施: Ocular Lubricant (Other)
结局指标
主要结局
Ocular comfort
时间窗: Up to Day 5
Comfort will be rated using a visual analog scale (0-100) from 0-100, where 0=poor and 100=excellent.
次要结局
未报告次要终点