NCT01240122已完成不适用
Short-Term Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Corneal Staining by Wear Time
研究概览
简要总结
An investigational multi-purpose solution (MPS)was clinically evaluated against Biotrue MPS at specific time points over the course of four days. The study was conducted with PureVision lenses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, 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
- 是
入选标准
- •were at least 18 years old;
- •were experienced contact lens wearers;
- •were correctable to at least 20/40 or better in both eyes with contact lenses;
- •were in good general health, with healthy eyes (other than requiring vision correction);
- •had not worn lenses for at least 12 hours before each baseline visit;
- •had a corneal staining score no greater than Grade 1 in either eye at time of enrollment;
- •had previously used an MPS or hydrogen peroxide solution successfully.
排除标准
- •had a confirmed diagnosis of Sjögren's syndrome or other condition that results in a chronic and/or pathologic dry eye condition;
- •required concurrent ocular medication or have used ocular medication within 24 hours of entering the study;
- •had a known sensitivity or intolerance to any MPS, study products or ingredient(s);
- •were currently participating in any other clinical study;
- •had a condition or are in a situation that, in the investigator's opinion, may put them at significant risk, confound the study results, or interfere significantly with their participation in the study.
研究组 & 干预措施
Biotrue MPS
Active Comparator
干预措施: Biotrue MPS (Device)
Investigational MPS
Experimental
干预措施: Investigational MPS (Device)
结局指标
主要结局
Corneal Staining by Wear Time
时间窗: 1 hour on Day 1, 2 hours on Day 2, 4 hours on Day 3 and End of Day on Day 4
All participants were contact lenses wearers and were evaluated with a Corneal Staining at 1 hour, 2 hours, 4 hours and end of day. The corneal staining test is performed using fluorescein drops in the eye and ultraviolet illumination to determine if there has been any damage to the cornea from the use of the lens solutions or from the use of the contact lens.
次要结局
- Subjective Solution Preference(Day 4)
- Overall Ocular Comfort(Day 4)
研究者
研究点 (2)
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