Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens
2018年6月18日 更新者：Johnson & Johnson Vision Care, Inc.
Dispensing Evaluation of a New Galyfilcon A Prototype and Avaira Lenses
The purpose of this study is to compare the visual acuity, limbal and bulbar redness of the new galyfilcon A prototype lenses against Avaira® lenses when worn as daily wear for seven (7) days.
研究概览
研究类型
介入性
注册 (实际的)
39
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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California
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Pismo Beach、California、美国
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Rhode Island
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Warwick、Rhode Island、美国
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Virginia
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Fincastle、Virginia、美国
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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 39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:
- The subject is a current spherical soft contact lens wearer and willing to wear the study lenses on a daily wear basis for the duration of the study.
- The subject's optimal vertexed spherical equivalent distance correction must be between -1.00 and - 5.00D.
- Any cylinder power must be ≤ -0.75D.
- The subject must have visual acuity best correctable to 20/25+3 or better for each eye.
- The subject must read and sign the Statement of Informed Consent.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
Exclusion Criteria:
- Ocular or systemic allergies or disease which might interfere with contact lens wear.
- Systemic disease or use of medication which might interfere with contact lens wear.
- Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
- Any ocular infection.
- Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
- Pregnancy or lactation.
- Diabetes.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- Habitual contact lens type is toric, multifocal, or is worn as extended 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：其他
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：galyfilcon A prototype lens/enfilcon A lens
galyfilcon A prototype contact lens worn daily for 6-8 days first then enfilcon A contact lens worn daily for 6-8 days second.
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Prototype silicone hydrogel contact lens
Marketed silicone hydrogel contact lens
其他名称：
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其他：enfilcon A lens/galyfilcon A prototype lens
enfilcon A contact lens worn daily for 6-8 days first then galyfilcon A prototype contact lens worn daily for 6-8 days second.
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Prototype silicone hydrogel contact lens
Marketed silicone hydrogel contact lens
其他名称：
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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 |
|---|---|---|
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Monocular Visual Acuity Assessment
大体时间：Post lens insertion (baseline)
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Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.
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Post lens insertion (baseline)
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Binocular Visual Acuity
大体时间：Post lens insertion (baseline)
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Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale.
A value <0 implies clinically positive results, a value >0 implies clinically negative results
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Post lens insertion (baseline)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Limbal Redness of Grade 3 or Above
大体时间：After 6-8 days of lens wear
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Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None).
Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis.
Grades 3 -5 are considered to be part of the adverse events reporting.
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After 6-8 days of lens wear
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Bulbar Redness of Grade 3 or Above
大体时间：After 6-8 days of lens wear
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Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None).
Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis.
Grades 3 -5 are considered to be part of the adverse events reporting.
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After 6-8 days of lens wear
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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。
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
2010年8月1日
初级完成 (实际的)
2010年9月1日
研究注册日期
首次提交
2010年8月30日
首先提交符合 QC 标准的
2010年8月31日
首次发布 (估计)
2010年9月1日
研究记录更新
最后更新发布 (实际的)
2018年6月19日
上次提交的符合 QC 标准的更新
2018年6月18日
最后验证
2016年5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.
近视的临床试验
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Tianjin Medical University Eye Hospital尚未招聘进行性近视 | 儿童近视 | Orthokeratology-related Myopia Progression
galyfilcon A prototype lens的临床试验
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CooperVision International Limited (CVIL)University of California, Berkeley招聘中