Comparative Evaluation of Corneal Staining With Balafilcon A Lenses and Two Multi-Purpose Solutions
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Eyes With No Change in Corneal Staining
研究概览
简要总结
A new multi-purpose solution (MPS)was clinically evaluated against Opti-Free RepleniSH 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
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（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
Opti-Free RepleniSH Multipurpose Solution (MPS, Control)
干预措施: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control) (Device)
RevitaLens OcuTec Multipurpose Solution (Investigational MPS)
干预措施: RevitaLens OcuTec MPS (Investigational MPS) and Opti-Free RepleniSH MPS (control) (Device)
结局指标
主要结局
Number of Eyes With No Change in Corneal Staining
时间窗: Change from baseline after 1, 2, 4 and 6+ hours of wear
Subjects examined after corneal staining (a method used to assess the condition of the cornea) using a slit lamp to determine change from baseline and rated based on the following scale: 0=no change from baseline, 1=trace, 2=mild, 3=moderate, 4=severe.
次要结局
未报告次要终点