SiH MPDS FID 114675A Compared to Renu Fresh MPS in Symptomatic Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 591
- 试验地点
- 1
- 主要终点
- Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
研究概览
简要总结
The purpose of this study is to compare two contact lens care solutions in symptomatic wearers of silicone hydrogel contact lenses.
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
- •Symptomatic silicone hydrogel contact lens wearers who wear their lenses daily wear (i.e., disinfect lenses every night).
- •Vision correctable to 20/30 or better with contact lenses.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Sensitivity to multi-purpose solutions.
- •Use of any topical ocular OTC or prescribed topical ocular medications.
- •History (6 months) or current ocular infections or ocular inflammatory events.
- •Ocular surgery within the past year.
- •Medical condition or use of medications that cause ocular side effects.
- •Participation in any investigational study within the past 30 days.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Alcon MPDS
MPDS used for 30 days as specified in protocol for contact lens care.
干预措施: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) (Device)
Alcon MPDS
MPDS used for 30 days as specified in protocol for contact lens care.
干预措施: Contact lenses (Device)
renu fresh MPS
MPS used for 30 days as indicated for contact lens care.
干预措施: renu fresh Multi-Purpose Solution (MPS) (Device)
renu fresh MPS
MPS used for 30 days as indicated for contact lens care.
干预措施: Contact lenses (Device)
结局指标
主要结局
Likert Statement: When I Use This Solution, I Can Comfortably Wear my Lenses.
时间窗: Day 30
As interpreted and reported by the subject on a questionnaire as a single, retrospective evaluation of the last three days of wearing experience. A 5-point Likert scale was used, where 1=strongly disagree, 2=disagree; 3=neither disagree nor agree; 4=agree; 5=strongly agree.
次要结局
- Likert Statement: When I Use This Solution, My Lenses Are Comfortable From Morning Until Evening.(Day 30)
- Likert Statement: When I Use This Solution, I Forget I am Wearing my Lenses.(Day 30)