Dispensing Study for the Phenacite Project
2020年10月30日 更新者：CooperVision, Inc.
Dispensing Study for the Phenacite Project.
The investigational test lens was not the final optical design and the study was not used for design validation.
研究概览
详细说明
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
研究类型
介入性
注册 (实际的)
25
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
-
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Indiana
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Bloomington、Indiana、美国、47405
- Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University
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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 35年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Oculo-visual examination in the last two years
- Between 18 and 35 years of age and has full legal capacity to volunteer
- Has read and understood the informed consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected
- Currently wears, or has previously successfully worn, soft contact lenses between -1.00D and -4.00D
- Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder ≤-0.75
- Has not worn lenses for at least 12 hours before the initial visit
- Has a subjective response at baseline, which indicates suitability for this study
- Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period
- Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week.
Exclusion Criteria:
- Has never worn contact lenses before
- Any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study.
- Has any ocular pathology or anomaly that would affect the wearing of the lenses
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye
- Is aphakic
- Has anisometropia of >1.00
- Has undergone corneal refractive surgery
- Has strabismus
- Has any ocular amblyopia >= 1line of HC Visual Acuity
- Is participating in any other type of eye related clinical or research study
- Has participated in study CV-14-32.
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：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Phenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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有源比较器：comfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
|
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 |
|---|---|---|
|
Subjective Ratings of Lens Comfort
大体时间：Baseline (after 15 minutes of lens dispense)
|
Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
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Baseline (after 15 minutes of lens dispense)
|
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Subjective Ratings of Lens Comfort
大体时间：2 Weeks
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Subjective ratings of lens comfort.
Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
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2 Weeks
|
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Over Refraction for Optimized Distance Acuity
大体时间：2 weeks
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Over Refraction for optimized distance acuity measured using logMAR
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2 weeks
|
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Binocular Distance Visual Acuity - High Illumination High Contrast
大体时间：Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
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Baseline (after 5 minutes of lens dispense)
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Binocular Distance Visual Acuity - High Illumination High Contrast
大体时间：2 weeks
|
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
大体时间：Baseline (after 5 minutes of lens dispense)
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Distance Visual Acuity - Low Illumination High Contrast
大体时间：2 weeks
|
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
大体时间：Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - High Illumination High Contrast
大体时间：2 weeks
|
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
|
2 weeks
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
大体时间：Baseline (after 5 minutes of lens dispense)
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
Baseline (after 5 minutes of lens dispense)
|
|
Binocular Near Visual Acuity - Low Illumination High Contrast
大体时间：2 weeks
|
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
|
2 weeks
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Lens Fit - Post Blink Movement
大体时间：Baseline (after 15 minutes of lens dispense)
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Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
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Baseline (after 15 minutes of lens dispense)
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Lens Fit - Post Blink Movement
大体时间：2 weeks
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Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
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2 weeks
|
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Push - Up Test for Lens Tightness
大体时间：Baseline (after 15 minutes of lens dispense)
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Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
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Baseline (after 15 minutes of lens dispense)
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Push - Up Test for Lens Tightness
大体时间：2 weeks
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Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
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2 weeks
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Lens Mobility Rating
大体时间：Baseline (after 15 minutes of lens dispense)
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Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
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Baseline (after 15 minutes of lens dispense)
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Lens Mobility Rating
大体时间：2 weeks
|
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (>1mm) on versions in all directions in 0.25 steps
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2 weeks
|
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Overall Lens Fit Acceptance
大体时间：Baseline (after 15 minutes of lens dispense)
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Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
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Baseline (after 15 minutes of lens dispense)
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Overall Lens Fit Acceptance
大体时间：2 weeks
|
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
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2 weeks
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Subjective Ratings for Vision Quality - Distance Vision
大体时间：Baseline (after 15 minutes of lens dispense)
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Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Distance Vision
大体时间：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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2 weeks
|
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Subjective Ratings for Vision Quality - Near Vision
大体时间：Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Near Vision
大体时间：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
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Subjective Ratings for Vision Quality - Computer Vision
大体时间：Baseline (after 15 minutes of lens dispense)
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Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
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Baseline (after 15 minutes of lens dispense)
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Subjective Ratings for Vision Quality - Computer Vision
大体时间：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
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Subjective Ratings for Vision Quality - Overall Vision
大体时间：Baseline (after 15 minutes of lens dispense)
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
Baseline (after 15 minutes of lens dispense)
|
|
Subjective Ratings for Vision Quality - Overall Vision
大体时间：2 weeks
|
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time.
Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
|
2 weeks
|
|
Corneal Staining Extent
大体时间：2 weeks
|
Corneal staining extent was assessed on a scale of 0-4 (0-No Staining, 1 - 1-15% of area, 2- 16-30% of area, 3- 31-45% of area, 4- >45% of area
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2 weeks
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Conjunctival Staining
大体时间：2 weeks
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Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
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2 weeks
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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。
调查人员
- 首席研究员：Pete Kollbaun, OD PhD、CORL Indiana University
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
2015年4月1日
初级完成 (实际的)
2015年7月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2015年5月1日
首先提交符合 QC 标准的
2015年5月1日
首次发布 (估计)
2015年5月6日
研究记录更新
最后更新发布 (实际的)
2020年11月18日
上次提交的符合 QC 标准的更新
2020年10月30日
最后验证
2020年10月1日
更多信息
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.