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Design Validation of Senofilcon A With New UV-blocking Additive

2019年11月15日 更新者：Johnson & Johnson Vision Care, Inc.
This is a 2-visit, multi-site, partially subject-masked, 2-arm parallel, controlled, randomized and dispensing trial. Subjects will be randomized to one of two study lenses for the entire duration of the study. The study lenses will be worn for a period of 2 weeks each in a bilateral fashion.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

253

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 美国
    • California
      • Cupertino、California、美国、95014
        • James T. Fujimoto, OD
    • Florida
      • Maitland、Florida、美国、32751
        • Maitland Vision Center
      • Tallahassee、Florida、美国、32308
        • Tallahassee Eye Center
    • Illinois
      • Bloomington、Illinois、美国、61701
        • Eyecare Associates LLP
    • Kansas
      • Pittsburg、Kansas、美国、66762
        • Kannarr Eye Care
    • Ohio
      • Granville、Ohio、美国、43023
        • Procare Vision Centers
      • Westerville、Ohio、美国、43081
        • Professional Vision Care, Inc
    • Tennessee
      • Memphis、Tennessee、美国、38111
        • Bradley Hines, OD
    • Texas
      • Tyler、Texas、美国、75703
        • Frazier Vision, Inc
    • Wisconsin
      • New Berlin、Wisconsin、美国、53151
        • Ziegler Leffingwell Eyecare

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 49年 (成人)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
    2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. Between 18 and 49 (inclusive) years of age at the time of informed consent.
    4. Eligible presbyopes will be those that wear full distance contact lenses in both eyes, then wear reading glasses over them when needed for near vision.
    5. The subject is a current spherical soft contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
    6. Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 5 days per week.
    7. Subjects must own a wearable pair of distance spectacles.
    8. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
    9. The subject's refractive cylinder must be 0.00 to -1.00 D (inclusive) in each eye.

    10. The subject must have a spherocylindrical best corrected distance Snellen visual acuity of 20/25+3 or better in each eye.

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
    2. Any active or ongoing systemic disease (e.g., Sjögren's Syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis).
    3. Subjects taking suspect oral medications for less than one year.
    4. Any prescribed or over the counter (OTC) ocular medication.
    5. Any known hypersensitivity or allergic reaction to Optifree® PureMoist® multi-purpose care solution or Eye-Cept® rewetting drop solution.
    6. Toric, extended wear, monovision or multi-focal contact lens correction.
    7. Any previous or planned (during the course of the study) ocular surgery (e.g., PRK, LASIK, etc.).
    8. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
    9. Participation in clinical trials involving the Test lens within 3 months prior to study enrollment.
    10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
    11. Binocular vision abnormality or strabismus by self-report or prior medical history.
    12. History of recurrent corneal erosions, herpetic keratitis, or pathological dry eye.
    13. Any active ocular allergies, infections or other ocular abnormalities (entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma) that the investigator determines may interfere with the outcomes of this study or otherwise contraindicate participation in the study.
    14. Any Grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA Slit Lamp Classification Scale.
    15. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar) within the past 3 years of otherwise successful contact lens wear.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：senofilcon A TEST Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the TEST Lens for the duration of the clinical study.
设备：senofilcon A TEST Lens
JJVC Investigational Contact Lens
有源比较器：senofilcon A CONTROL Lens
Subjects between 18 to 49 years of age that are habitual wearers of spherical soft contact lenses will be randomized into the CONTROL Lens for the duration of the clinical study.
设备：senofilcon A CONTROL Lens
Acuvue Oasys

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Overall Comfort Score
大体时间：2-Week Follow-up Evlauation
Overall comfort was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Vision Satisfaction in Bright Lighting
大体时间：2-Week Follow-up Evaluation
Vision satisfaction in bright light was assessed using the individual item" I was satisfied with the quality of my vision in bright lighting" from the CLUE™ questionnaire. This item used the response scale, 1: Strongly Disagree, 2: Disagree, 3: Neither Agree nor Disagree, 4: Agree and 5: Strongly Agree. CLUE is the Contact Lens User Experience™ questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The Proportion of responses in each category were reported for each lens type.
2-Week Follow-up Evaluation
Distance Visual Acuity
大体时间：2-Week Follow-up Evlauation
Distance visual acuity was assessed by eye using LogMAR visual acuity at 4 meters using an ETDRS chart under high illumination high contrast conditions (room illumination > 400 lux and chart luminance 120-200 cd/m2) at the 2-week follow-up for each subject eye. Lower values of logMAR indicate better vision, where a score of 0.0 equates to 20/20 snellen vision. The average visual acuity for each lens was reported.
2-Week Follow-up Evlauation
Contact Lens Fitting Acceptance Rate
大体时间：Up to 2-Week Follow-up

Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each subject eye. Fit acceptance rate will be based on the lens fit acceptance of eyes wearing the Test lens only. Fit acceptance is a binary response where Y=1 if lens fit is acceptable and Y=0 otherwise. Unacceptable is defined as unacceptable if any one of the following criteria:

  • limbal exposure at primary gaze or with extreme eye movement;
  • edge lift;
  • excessive movement in primary up gaze;
  • insufficient movement in all three of the following conditions: primary gaze, up gaze, and push up test.

Eyes with multiple unacceptable fitting events will be counted only once. Fit rates of the Control lens will also be collected but are not a primary endpoint.
Up to 2-Week Follow-up
Number of Grade 3 or Higher Slit Lamp Findings
大体时间：Up to 2-Week Follow-up Evlauation
Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). Slit Lamp Findings will be assessed for each subject eye at all study visits (schedule and unscheduled). SLF is a binary response where Y=1 for at least one Grade 3 or 4 slit lamp finding. The percentage of eyes with Grade 3 or higher slit lamp findings will be analyzed and will include corneal infiltrates. Eyes with multiple events will be counted only once. The number of eyes with SLF with grade 3 or higher by lens was reported.
Up to 2-Week Follow-up Evlauation

次要结果测量

结果测量
措施说明
大体时间
Overall Handling Score
大体时间：2-Week Follow-up Evlauation
Overall handling was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation
Overall Quality of Vision Score
大体时间：2-Week Follow-up Evlauation
Overall quality of vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patientexperience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
2-Week Follow-up Evlauation

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Johnson & Johnson Vision Care, Inc.

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年10月1日

初级完成 (实际的)

2018年11月1日

研究完成 (实际的)

2018年11月1日

研究注册日期

首次提交

2018年10月12日

首先提交符合 QC 标准的

2018年10月12日

首次发布 (实际的)

2018年10月16日

研究记录更新

最后更新发布 (实际的)

2019年12月5日

上次提交的符合 QC 标准的更新

2019年11月15日

最后验证

2019年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • CR-6305

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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