Comparison of Two One-Step Hydrogen Peroxide Lens Care Solutions in Symptomatic Contact Lens Wearers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 主要终点
- Mean Residual Peroxide at Day 30
研究概览
简要总结
The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.
详细描述
Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.
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
- 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
- •Sign informed consent form;
- •Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
- •Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
- •Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Current hydrogen peroxide-based solution user;
- •Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
- •Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
- •Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
- •Use of systemic or ocular medications for which contact lens wear could be contraindicated;
- •Monocular (only 1 eye with functional vision) or fit with only 1 lens;
- •History of herpetic keratitis, ocular surgery, or irregular cornea;
- •Other protocol-specified exclusion criteria may apply.
研究组 & 干预措施
Clear Care Plus, then PeroxiClear
Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
干预措施: Clear Care Plus contact lens solution (Device)
Clear Care Plus, then PeroxiClear
Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
干预措施: PeroxiClear contact lens solution (Device)
Clear Care Plus, then PeroxiClear
Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
干预措施: Silicone hydrogel contact lenses (Device)
PeroxiClear, then Clear Care Plus
PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
干预措施: Clear Care Plus contact lens solution (Device)
PeroxiClear, then Clear Care Plus
PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
干预措施: PeroxiClear contact lens solution (Device)
PeroxiClear, then Clear Care Plus
PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
干预措施: Silicone hydrogel contact lenses (Device)
结局指标
主要结局
Mean Residual Peroxide at Day 30
时间窗: Day 30, each product
The used lens case was collected after approximately 30 days of use. Remaining liquid was removed and dry cases were shipped to a lab for analysis. 10 mL of the appropriate solution was added to each collected case. Residual peroxide was measured at the manufacturers minimum recommended storage time (6 hours for Clear Care Plus and 4 hours for PeroxiClear).
次要结局
- Mean Osmolality in Lens Cases at Day 30(Day 30, each product)