Evaluation of the Performance of AIR OPTIX® COLORS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- Visual Acuity
研究概览
简要总结
The purpose of this study was to assess the ocular response to and performance of the cosmetically printed silicone hydrogel contact lens AIR OPTIX® COLORS compared to FRESHLOOK® COLORBLENDS.
详细描述
The study was conducted in two phases. Phase 1 was an adaptation phase where participants wore AIR OPTIX® AQUA contact lenses bilaterally (same product in both eyes) on a daily wear basis for 1 week. In Phase 2, participants wore AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS contact lenses contralaterally (different product in each eye) on a daily wear basis for 4 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full legal capacity to volunteer;
- •Read and sign information and consent letter;
- •Willing and able to follow instructions and maintain the appointment schedule;
- •Ocular examination in the last two years;
- •Currently wears soft contact lenses on a daily wear basis;
- •Contact lens prescription between -1.50 diopters and -5.00 diopters;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Any ocular disease;
- •Any systemic condition that may affect a study outcome variable;
- •Any systemic or topical medications that may affect ocular health;
- •Known sensitivity to the diagnostic pharmaceuticals used in the study;
- •Unable to achieve an acceptable fit with the study lenses;
- •Anisometropia >1.00 diopter or astigmatism >0.75 diopter;
- •Use of lubricating/rewetting eye drops.
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Visual Acuity
时间窗: Phase 2: Up to Week 4
Corneal Staining
时间窗: Phase 2: Up to Week 4
Conjunctival Staining
时间窗: Phase 2: Up to Week 4
Surface Regularity Index (SRI)
时间窗: Up to Phase 2, Week 4
Surface Asymmetry Index (SAI)
时间窗: Up to Phase 2, Week 4
Subjective ratings
时间窗: Phase 2: Up to Week 4
次要结局
未报告次要终点