A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 805
- 试验地点
- 35
- 主要终点
- Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
研究概览
简要总结
The objective of this study is to evaluate the product performance of kalifilcon A, compared to the Johnson & Johnson Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens and Alcon DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 40 years old on the date the ICF is signed and have capacity to provide voluntary informed consent.
- •myopic and require lens correction from -0.50 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
- •correctable through spherocylindrical refraction and with soft spherical contact lenses to 32 letters (0.3 logarithm of the minimum angle of resolution [logMAR]) or better (2 meters distance, high-contrast chart) in each eye.
- •free of any anterior segment disorders.
- •adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day on a daily disposable wear basis for approximately 2 weeks.
- •access to internet connection and personal email to send/receive emails.
- •habitually wear either Alcon's Air Optix Aqua, Air Optix with HydraGlyde, Air Optix Night & Day, Bausch + Lomb's PureVision 2, Bausch + Lomb ULTRA, CooperVision's Biofinity, Johnson & Johnson Acuvue Oasys® with HydraClear™, or Acuvue Vita soft contact lenses.
排除标准
- •participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening/Dispensing Visit) and/or during the period of study participation.
- •have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- •have any systemic or ocular disease currently affecting ocular health in the Investigator's opinion may have an effect on ocular health during the course of the study.
- •using any systemic, topical or topical ocular medications that will in the Investigator's opinion, affect ocular physiology or lens performance.currently wear daily disposable, monovision, multifocal, or toric contact lenses.
- •refractive astigmatism of greater than 0.75 D in either eye.
- •anisometropia (spherical equivalent) of greater than 2.00 D.
- •amblyopic.
- •have had any corneal surgery (e.g., refractive surgery).
研究组 & 干预措施
kalifilcon A
kalifilcon A daily disposable contact lens
干预措施: kalifilcon A (Device)
delefilcon A
DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
干预措施: delefilcon A (Device)
senofilcon A
Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
干预措施: senofilcon A (Device)
结局指标
主要结局
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Are Comfortable Throughout the Day"
时间窗: 2 Week Follow up
Percentage of Participants in the Test Lens Group Agreeing With the Statement "Provide Clear Vision Throughout the Day"
时间窗: 2 Week Follow up
Mean Change in logMAR Contact Lens Visual Acuity
时间窗: Baseline, 2 Week Follow up
logMAR is the logarithm of the minim angle of resolution
次要结局
未报告次要终点