NCT05660577已完成不适用
A Study to Evaluate the Product Performance of a New Silicone Hydrogel Multifocal Contact Lens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 301
- 试验地点
- 40
- 主要终点
- Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
研究概览
简要总结
The objective of this study is to evaluate the product performance of a new silicone hydrogel daily disposable multifocal contact lens, the Bausch + Lomb (kalifilcon A) Daily Disposable Multifocal Contact Lens, when worn by current soft contact lens wearers on a daily disposable wear basis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be age 40 years or older on the date the ICF is signed and have the capacity to provide voluntary informed consent
- •Subjects must be willing and able to comply with all treatment and follow-up/study procedures, as well as willing and able to refrain from using any contact lenses other than those provided for the duration of the study
- •Subjects must be correctable through spherocylindrical refraction to 42 letters (0.1 logMAR) or better (distance, high contrast) in each eye
- •Subjects must have clear central corneas and be free of any anterior segment disorders
- •Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week
- •Subjects must habitually wear a multifocal lens in each eye
- •Subjects must be an adapted multifocal soft contact lens wearer for a minimum of 6 months
- •Subjects must require distance lens correction from +3.00 to -6.00 D in each eye
- •Subjects must be presbyopic and require near add correction from +0.75 to +2.50 D in each eye
- •Subjects must have access to an internet connection to complete an online survey and be able to receive text message
排除标准
- •Subjects participating in any drug or device clinical investigation within 30 days prior to entry into this study and/or plan to do so during the period of study participation
- •Subjects who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they meet any one of the following conditions:
- •She is currently pregnant
- •She plans to become pregnant during the study
- •She is breastfeeding
- •Subjects with any systemic disease currently affecting ocular health or that, in the Investigator's opinion, may have an effect on ocular health during the course of the study
- •Subjects with an active ocular disease
- •Subjects who have had any corneal surgery (e.g., refractive surgery)
- •Subjects who have worn gas-permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last 3 months
- •Subjects who currently wear monovision or toric contact lenses
- •Subjects who are not correctable to 32 letters (0.3 logMAR) with bilateral soft multifocal contact lenses
- •Subjects with an ocular astigmatism >1.00 D in either eye
- •Subjects with anisometropia (spherical equivalent) >2.00 D
- •Subjects with any Grade ≥2 finding during the slit lamp examination. Subjects with corneal infiltrates of ANY GRADE are not eligible
- •Any "Present" finding during the slit lamp examination that, in the Investigator's opinion, interferes with contact lens wear
- •Any scar or neovascularization within the central 6 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area) that, in the Investigator's opinion, does not interfere with contact lens wear are eligible for this study
- •Subjects who are amblyopic
- •Subjects using any systemic or topical ocular medication that will, in the Investigator's opinion, affect ocular physiology or lens performance
- •Subjects who are allergic to any component in the study care products
结局指标
主要结局
Proportion of Subjects Agreeing With the Statement "Clear Vision: Near, Far, and In-between
时间窗: 3 weeks
次要结局
未报告次要终点
研究者
研究点 (40)
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