A Safety and Effectiveness Study of a Contact Lens Cleaning and Disinfecting Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 295
- 试验地点
- 38
- 主要终点
- Overall Comfort Averaged Over All Follow-up Visits
研究概览
简要总结
Approximately 340 participants (680 eyes) will be enrolled in this three-month, two-arm, 1:1 randomized, parallel-group, bilateral, double-masked study at approximately 22 investigative sites in the United States. Participants will be required to wear dispensed study lenses on a daily wear basis for three months with scheduled in-office replacement of study lenses at the 1-Month and 2-Month Follow-Up Visits.
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
- Double (Participant, Investigator)
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
- •Is of legal age (at least 18) on the date the Informed Consent Form (ICF) is signed
- •Is able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as appropriate for local privacy regulations
- •Is a habitual wearer (at least 3 months)
- •Has typically cleaned and disinfected their pre-study contact lenses daily
- •Must have spectacle correctable distance visual acuity through spherocylindrical refraction to 40 letters (0.14 logarithm of the minimal angle of resolution (logMAR) or better in each eye, at 2 meters distance with high contrast chart
- •Has clear central corneas and is free of any anterior segment disorders
- •Is a habitual user of a lens care product for cleaning, disinfecting, and storage of lenses
- •Requires lens correction in both eyes
- •Wears the same manufacturer and brand of lens in both eyes
- •Agrees to wear study lenses on a daily wear basis for approximately three months
- •Is willing and able to comply with all treatment and follow-up/study procedures.
排除标准
- •Is currently using a hydrogen-peroxide cleaning and disinfecting solution
- •Participated in any drug or device clinical investigation within 30 days prior to entry into this study
- •Is a female of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following conditions:
- •they are currently pregnant
- •they plan to become pregnant during the study
- •they are breastfeeding
- •Has worn gas permeable (GP) lenses within the last 30 days
- •Has worn polymethylmethacrylate (PMMA) lenses within the last three months
- •Has typically worn their pre-study contact lenses on an extended wear basis, sleeping in their lenses one night or more per week, during the last year
- •Has any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study
- •Subjects with an active ocular disease, or who are using any ocular medication.
- •Is using any medications that will, in the Investigator's opinion, affect ocular physiology or lens performance
- •Currently wears monovision, multifocal, or toric contact lenses
- •Has ocular astigmatism of 1.00D or greater in either eye
- •Has anisometropia (spherical equivalent) of greater than 2.00D
- •Has any grade 2 or greater finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation)
- •Has corneal infiltrates, of ANY GRADE
- •Has any "Present" ungraded finding during the slit-lamp examination (refer to Appendix B for Methods of Clinical Evaluation) that, in the Investigator's judgment, interferes with contact lens wear.
- •Has typically worn their pr-study control lenses on an extended wear bases, sleeping on their lenses one night or more per week, during the last year.
- •Is amblyopic
- •Has had any corneal surgery (e.g., refractive surgery)
- •Is allergic to any component in the study care products.
- •Is an employee of any of the study investigative sites or a family member of an employee of the investigative site, including family members living outside of the employee's household
- •Is an Ophthalmologist, an Optometrist, an Optician, or an Ophthalmic Assistant/Technician, or currently resides with a person with any of these specialties
- •Is an employee of a manufacturer of contact lenses or contact lens care products (e.g., Alcon, Bausch + Lomb, Ciba Vision, CooperVision, Vistakon, Johnson & Johnson, etc.) or currently resides with a person employed by any of these manufacturers.
结局指标
主要结局
Overall Comfort Averaged Over All Follow-up Visits
时间窗: Assessed at all follow-up visits through 3 months.
Overall comfort will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
The Proportion of Eyes With a Maximum Degree of Front Surface Deposits Grade of <= 2 Over All Follow-up Visits With 0 Being Absent of Deposits.
时间窗: Assessed at all follow-up visits through 3 months.
The degree of front surface deposits will be graded for each eye as: 0 - Absent, clean surface. 1. \- Very slight, only visible after tear film drying. 2. \- Slight, visible deposits easily removable. 3. \- Moderate, deposits adherent and not removable. 4. \- Severe, non-removable deposits and comfort affected.
Vision Averaged Over All Follow-up Visits
时间窗: Assessed at all follow-up visits through 3 months.
Vision will be assessed for each eye on a scale from 0 to 100, with 100 denoting the most favorable response
The Proportion of Eyes With Any Slit-lamp Findings Greater Than Grade 2 Over All Follow-up Visits.
时间窗: Assessed at 3 months
Graded slit-lamp findings will be assessed for each eye using Grades 0 through 4.
次要结局
未报告次要终点