Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 89
- 主要终点
- Lens Fit
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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.
- •History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit
- •Wear contact lenses a minimum of 8 hours per day prior to Visit
- •Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
- •Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit
- •Pre-study use of rewetting drops is acceptable.
- •History of intolerance or known sensitivity to any component of the treatments.
- •Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
FID 114576A / renu fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
干预措施: Galyfilcon A contact lenses (Acuvue Advance) (Device)
FID 114576A / renu fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
干预措施: FID 114675A multi-purpose disinfecting solution (MPDS) (Device)
FID 114576A / renu fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
干预措施: renu fresh Multi-Purpose Solution (MPS) (Device)
renu fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
干预措施: FID 114675A multi-purpose disinfecting solution (MPDS) (Device)
renu fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
干预措施: renu fresh Multi-Purpose Solution (MPS) (Device)
renu fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
干预措施: Galyfilcon A contact lenses (Acuvue Advance) (Device)
结局指标
主要结局
Lens Fit
时间窗: Day 14 of lens wear
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
次要结局
- Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score(Day 14 of lens wear)