Subjective Comfort With Multipurpose Care Solutions in Soft Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
研究概览
简要总结
The purpose of this study was to assess the comfort of OPTI-FREE RepleniSH in soft contact lens wearers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
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
- •Currently wearing silicone hydrogel contact lenses on a daily wear basis;
- •Currently using OPTI-FREE RepleniSH contact lens solution;
- •Generally healthy;
- •Normal ocular health;
- •Willing to follow study procedures and visit schedule;
- •Sign Informed Consent and privacy document;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Use of additional lens cleaners;
- •Known sensitivities to any ingredient in either test article;
- •Systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study;
- •History of ocular surgery/trauma within the last 6 months;
- •Any topical ocular or systemic antibiotics within 7 days of enrollment continuing throughout the study;
- •Participation in any other ophthalmic drug or device clinical trial within 30 days of enrollent;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
OPTI-FREE RepleniSH
OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
干预措施: OPTI-FREE RepleniSH multipurpose solution (Device)
OPTI-FREE RepleniSH
OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
干预措施: Silicone hydrogel contact lenses (Device)
ReNu Biotrue
ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
干预措施: ReNu Biotrue multipurpose solution (Device)
ReNu Biotrue
ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
干预措施: Silicone hydrogel contact lenses (Device)
结局指标
主要结局
Change From Baseline (Day 0) in Ocular Comfort Rating at Day 14
时间窗: Baseline (Day 0), Day 14
Ocular comfort was rated by the participant on a continuous visual analog scale from 0-100, where 0=extremely uncomfortable, 50=neither comfortable nor uncomfortable, and 100=extremely comfortable. The participant marked a horizontal line across the scale at the point that best described, "how your eyes feel right now." A positive number indicates increased ocular comfort; a negative number indicates decreased ocular comfort.
次要结局
未报告次要终点