A Study to Evaluate the Safety and Efficacy of a Kalifilcon A Contact Lens for Daily Disposable Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 252
- 试验地点
- 32
- 主要终点
- Mean logMAR Contact Lens Visual Acuity
研究概览
简要总结
This study is to evaluate the safety and efficacy of a new silicone hydrogel daily disposable contact lens, kalifilcon A compared to the Bausch + Lomb Biotrue ONE day® daily disposable contact lens when worn by current soft contact lens wearers on a daily disposable wear basis.
详细描述
Approximately 247 participants (494 eyes) will be enrolled in at approximately 20 investigative sites in the United States (US). A minimum of 20% of the randomized participants will be of Japanese descent (for example, both maternal and paternal grandparents born in Japan).
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB) approved Informed Consent Form (ICF) and provide authorization as appropriate for local privacy regulations.
- •Participants must be myopic and require lens correction from -0.25 to -6.00 Diopter (D) with 0.25 D steps, in each eye.
- •Participants must be correctable through spherocylindrical refraction and with soft spherical contact lenses to 40 letters (0.14 logMAR) or better (2 meters distance, high-contrast chart) in each eye.
- •Participants must be free of any anterior segment disorders.
- •Participants must be adapted soft contact lens wearers and willing to wear their study lenses for at least 8 hours per day at least 5 days per week on a daily disposable wear basis for approximately 3 months.
- •Participants 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 other contact lenses or solutions other than those provided for the duration of the study.
排除标准
- •Participation 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.
- •Participants who are women of childbearing potential (those who are not surgically sterilized or postmenopausal) are excluded from participation in the investigation if they are currently pregnant, plans to become pregnant during the study, or is breastfeeding
- •Participants 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.
- •Participants with any systemic disease currently affecting ocular health or in the Investigator's opinion may have an effect on ocular health during the course of the study.
- •Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- •Participants with an active ocular disease or who are using any ocular medication.
- •Participants who currently wear monovision, multifocal, or toric contact lenses.
- •Participants with an ocular astigmatism of greater than 1.00 D in either eye.
- •Participants with anisometropia (spherical equivalent) of greater than 2.00 D.
- •Participants with any Grade 2 or greater finding during the slit lamp examination. Participants with corneal infiltrates of any grade.
- •Participants with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- •Participants with any scar or neovascularization within the central 6 millimeters (mm) of the cornea.
- •Participants who are aphakic.
- •Participants who are amblyopic.
- •Participants who have had any corneal surgery (for example, refractive surgery).
- •Participants who are allergic to any component in the study care products.
- •The participant is an employee of the investigative site.
- •The participant, or a member of the participant's household, is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician.
- •The participant, or a member of the participant's household, is an employee of a manufacturer of contact lenses or contact lens care products (for example, Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Johnson & Johnson).
- •The participant, or a member of the participant's household, is an employee of a market research firm.
结局指标
主要结局
Mean logMAR Contact Lens Visual Acuity
时间窗: 3 months
Visual acuity (VA) will be reported as letters read correctly, and the letters read will be converted to logarithm of the minimum angle of resolution (logMAR) acuity. The participant will read rows of letters on a standard LogMAR chart until the participant misses 3 letters on a row with 5 letters. The total number of correct letters will be recorded. A decrease in the number of correct letters indicates a decrease in visual acuity. Acuity will be averaged across visits.
Proportion of Participants With Slit Lamp Findings Greater Than Grade 2
时间窗: 3 months
During an examination of both eyes without lenses, graded slit lamp findings will be assessed for each eye using Grades 0 (none), 1 (trace), 2 (mild), 3 (moderate), and 4 (severe). Using only the non-missing observations from all visits without imputation, each eye will be classified with respect to findings greater than Grade 2 at any visit (Absent or Present). Epithelial edema, epithelial microcysts, corneal staining, limbal Injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates will be evaluated.
次要结局
未报告次要终点