A Study to Evaluate the Clinical Performance of a Novel Multipurpose Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Comfort-related Symptoms/Complaints
研究概览
简要总结
The objective of this study is to evaluate the clinical performance of Bausch & Lomb investigational Multi-Purpose Solution compared to Ciba Vision Multi-Purpose Solution when used by wearers of silicone hydrogel or Group IV 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
- Single (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
- 是
入选标准
- •Participants must be of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
- •Participants must habitually use a lens care product for lens cleaning, disinfecting, and storage.
- •Participants must wear a lens in each eye and each lens must be of the same manufacture and brand.
- •Participants must agree to wear study lenses on a daily wear basis.
- •Participants must be able and willing to comply with all treatment and follow-up/study procedures.
排除标准
- •Participants participating in any drug or device clinical investigation within 2 weeks prior to entry into this study and/or during the period of study participation.
- •Participants with any systemic disease affecting ocular health.
- •Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Participants who have had any corneal surgery (eg, refractive surgery).
- •Participants who are allergic to any component in the study care products.
研究组 & 干预措施
Bausch & Lomb Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
干预措施: Bausch & Lomb Multi-Purpose Solution (Device)
Ciba's Multi-Purpose Solution
Multi-Purpose Solution to be used for disinfecting contact lenses.
干预措施: Ciba's Multi-Purpose Solution (Device)
结局指标
主要结局
Comfort-related Symptoms/Complaints
时间窗: At dispensing visit and each follow-up visit at week 2 and week 4.
Participants rated their subjective symptoms/complaints using a 0 to 100 scale for each eye. A 0 represented the least favorable rating, and a 100 represented the most favorable rating. Over All Follow-Up Visits summarizes the average over all follow-up visit summaries.
次要结局
- Slit Lamp Findings(Over all visits for 1 month)