Effect of SiH MPDS FID 114675A vs. a Marketed Multi-Purpose Solution on Lens Moisture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Mean Ex-Vivo Advancing Contact Angle
研究概览
简要总结
The purpose of the study is to evaluate the effect of an investigational multi-purpose disinfecting solution (MPDS) compared to a marketed multi-purpose solution on the moisture 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
- 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
- 否
入选标准
- •18 years of age or older.
- •Wears silicone hydrogel contact lenses on a daily wear basis i.e. disinfects lenses every night).
- •Has successfully worn contact lenses for 5 days, 8 hours per day, prior to baseline visit.
- •Vision is correctable to 20/30 or better in each eye at distance with study lenses at baseline visit.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Known sensitivity or intolerance to contact lens multi-purpose solutions.
- •Use of any topical ocular OTC or prescribed topical ocular medications.
- •History or current ocular infections or ocular inflammatory events.
- •Ocular surgery within the past year.
- •Medical condition or use of medication 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
FID 114675A
Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
干预措施: FID 114675A Multi-Purpose Disinfecting Solution (MPDS) (Device)
FID 114675A
Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
干预措施: Silicone Hydrogel Contact Lenses (Device)
ReNu MultiPlus
Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
干预措施: ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS) (Device)
ReNu MultiPlus
Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
干预措施: Silicone Hydrogel Contact Lenses (Device)
结局指标
主要结局
Mean Ex-Vivo Advancing Contact Angle
时间窗: Day 8, 16 hours
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
Mean Ex-Vivo Advancing Contact Angle
时间窗: Day 1, 8 hours
Study lens was removed from the eye according to protocol-specified procedures. The OCA15 (Optical Contact Angle) Instrument was used to observe, record, and calculate contact angle measurements. The wetting angle measurement was recorded in degrees (0-180), and a lower wetting angle measurement indicates a more wettable lens.
次要结局
未报告次要终点