Clinical Safety and Effectiveness of ASP-57 Multi-Purpose Contact Lens Care Solution Compared to a Marketed Contact Lens Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 315
- 试验地点
- 14
- 主要终点
- Visual Acuity
研究概览
简要总结
The objective of this study is to evaluate the safety and effectiveness of ASP-57 Multi-Purpose contact lens solution (Test) compared to ReNu® Multiplus Contact Lens Solution (Control) when used by habitual contact lens wearers to bilaterally clean and disinfect their contact lenses for approximately 3 months (12 weeks).
详细描述
Approximately 330 subjects (660 eyes) will be enrolled in this 3 month (12 week) controlled, parallel group, masked, randomized study at approximately 15 investigative sites in the United States. Subjects will be randomized 2:1 to receive either Asepticys ASP-57 Multi-Purpose Solution or ReNu® Multiplus Contact Lens Solution (Control) respectively. Both Test and Control solution will be used with a rub care regimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Subjects age ≥ 18 years on the date of informed consent.
- •All subjects must provide signed written consent prior to participation in any study related procedures.
- •Successful history of wear of the one of the following lens types (toric and multifocal lenses of the specified lens type are allowed) in both eyes during the past 3 months, and history of at least 5 consecutive days of successful daily wear in both eyes prior to Visit 1:
- •All Bausch & Lomb PureVision lens types
- •All Alcon Air Optix lens types
- •All CooperVision Biofinity lens types
- •All Vistakon Acuvue Oasys lens types
- •Any conventional hydrogel Group IV lens
- •Vision correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- •Clear central corneas and free of any anterior segment disorders
- •Habitual use of a Multi-Purpose Solution for cleaning, disinfecting, and storage of lenses.
- •Lens correction in both eyes is required and the same brand of lens is worn in each eye.
- •Agree to wear study lenses in both eyes on a daily wear basis, with lenses removed every night (not slept in) throughout the study period and no lens or pair of lenses worn for longer than 2 weeks.
- •Able and willing to comply with all care regimen and follow-up study procedures.
排除标准
- •Females of childbearing potential (not surgically sterilized or postmenopausal) if any one of the following conditions are met:
- •currently pregnant,
- •plan to become pregnant during the study,
- •are breast-feeding.
- •Wear of gas permeable contact lenses within the last 30 days.
- •Wear of polymethylmethacrylate lenses within the last 3 months.
- •No topical ocular prescription medications may be administered during the study period. Ongoing use of non-preserved artificial tears up to 4 times daily (with no changes in frequency or brand) is allowed. Ongoing use of the rewetting drop the subject customarily uses (with no switch in brand or type) is also permitted during the study period.
- •Current systemic disease affecting ocular health or use of topical or systemic medications that, in the Investigator's opinion, could affect ocular physiology or lens performance.
- •Ocular astigmatism of 2.00 D or greater in either eye based on the contact lens prescription.
- •Grade 2 or greater finding on any slit-lamp scale and/or corneal infiltrates of any grade during slit-lamp examination at Screening.
- •Any finding during slit-lamp examination that, in the Investigator's opinion, interferes with contact lens wear.
- •Scar or neovascularization within the central 4 millimeters (mm) of the cornea. Minor peripheral corneal scarring (that does not extend into the central zone) is permitted, if in the Investigator's judgment, it does not interfere with contact lens wear.
- •History of any corneal surgery.
- •Allergy to any component of the study solutions.
- •Participation in any clinical study within the 2 weeks prior to entry into this study.
研究组 & 干预措施
Asepticys investigational ASP-57 Multi-Purpose Solution
ASP-57 Multi-Purpose contact lens care solution used as a rub care regimen (Test)
干预措施: ASP-57 (Device)
ReNu® Multiplus Contact Lens Solution
ReNu® Multiplus Contact Lens Solution used as rub care regimen (Control)
干预措施: ReNu® Multiplus (Device)
结局指标
主要结局
Visual Acuity
时间窗: 3 months
Statistical non-inferiority with respect to the proportion of subjects with greater than 2-line worsening in visual acuity in any eye at any visit between the test and control solutions
Slit Lamp Findings
时间窗: 3 months
Statistical non-inferiority with respect to the proportion of eyes with any slit-lamp findings greater than Grade 2 at any visit between the test and control solutions
次要结局
未报告次要终点