NCT01543061已完成4 期
Evaluation of the Effect of Repeated Usage of a New Eyedrop on Silicone Hydrogel Contact Lens Wearers With Dry Eye Complaints
Optometric Technology Group Ltd2 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2012年2月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Tear Break up Time
研究概览
简要总结
The objectives of the investigation will be to assess the effect of the repeated usage of a new eye drop on the tear film characteristics of silicone hydrogel contact lens wearers with contact lens related comfort problems and to quantify any potential benefit.
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
- Double (Participant, Outcomes Assessor)
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
- •Current silicone hydrogel contact lens wearer
- •Complaints of contact lens related dry eye (Symptoms and reduced comfortable wearing time)
排除标准
- •Known allergy or sensitivity to the study product(s) or its components
- •Systemic or ocular allergies
- •Use of systemic medication which might have ocular side effects.
- •Any ocular infection.
- •Use of ocular medication.
- •Significant ocular tissue anomaly
结局指标
主要结局
Tear Break up Time
时间窗: 30 days
次要结局
- Comfort, vision and ocular symptoms questionnaire(30 days)
- Conjunctival staining measurement(30 days)
- Ocular Surface Disease Index questionnaire(30 days)
- Tear film evaporation rate(30 days)
- Post wear contact lens deposition and lipid uptake assessment(30 days)
研究者
研究点 (2)
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