Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- Mean Ex-Vivo Total Lipid Uptake Per Lens
研究概览
简要总结
The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.
详细描述
This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Participant)
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
- •Read and understand the Participant Information Sheet;
- •Read, sign, and date the Informed Consent;
- •Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
- •Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
- •Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
- •Best corrected visual acuity of 6/9 or better in each eye;
- •Normal eyes with the exception of the need for visual correction;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
- •Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
- •Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
- •Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
- •Systemic or ocular allergies which might interfere with contact lens wear;
- •Ocular disease which might interfere with contact lens wear;
- •Active ocular infection;
- •Use of any concomitant topical ocular medications during the study period;
- •Previous ocular surgery;
- •Pregnant, planning to become pregnant, or lactating at the time of enrollment;
- •Participation in an investigational drug or device study within 30 days of entering this study;
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Mean Ex-Vivo Total Lipid Uptake Per Lens
时间窗: Day 30
The contact lens was aseptically removed from the eye. Lipids were extracted and analyzed using a proprietary High Performance Liquid Chromatography technique. A lower value indicates a cleaner lens surface. One eye (study eye) contributed to the mean.
次要结局
- Mean Non-Invasive Pre-Lens Tear Film Break Up Time (NIBUT)(Day 30)
- Average Exposure Speed(Day 30)
- Overall Comfort Measured With Visual Analog Scale (VAS)(Day 30)
- LogMAR Time-Controlled Visual Acuity (TCVA)(Day 30)
- Overall Dryness Measured With Visual Analog Scale (VAS)(Day 30)
- Minimum Protected Area(Day 30)