BIOCLEAN MPS (Multi-Purpose Solution) VII in Combination With Biofinity Lens: A Two Week Crossover Study
2020年8月4日 更新者:CooperVision, Inc.
Two week, Open Label, randomized, bilateral, crossover, 1 week of daily wear in each combination (lens / disinfecting cleaning system).
研究概览
详细说明
To determine if patients are unreactive to the lens care solution / Biofinity combination.
It is expected that there will be a total of three visits: V1 (Initial), V2 (1 week), & V3 (2 weeks).
研究类型
介入性
注册 (实际的)
33
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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Kyoto-fu
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Joyo-shi、Kyoto-fu、日本、610-0121
- Kodama Eye Clinic
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Kameoka、Kyoto-fu、日本、621-0861
- Higashihara Eye Clinic
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Osaka-fu
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Osaka-shi、Osaka-fu、日本、542-0082
- Iwasaki Eye Clinic
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Is over 18 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Has a CL (contact lens) spherical prescription between -0.25D (Diopters) and -12.00D (inclusive)
- Has less than 1.00 D spectacle cylinder in each eye
- Is correctable to a visual acuity of 20/20 or better in both eyes
- Has clear corneas and no active ocular disease
- Has read, understood and signed the informed consent letter
- Is willing to comply with the wear schedule (at least 40hrs per week)
- Is willing to comply with the visit schedule
Exclusion Criteria:
- Has never worn contact lenses before
- Currently wears rigid gas permeable contact lens
- Has a history of not achieving comfortable CL (contact lens) wear (5 days per week; > 8 hours per day)
- Has a CL prescription outside the range of -0.25D to -12.00D
- Has a spectacle cylinder greater than -0.75D of cylinder in either eye
- Has best corrected spectacle distant vision worse than 20/20 in ether eye
- Has any systemic disease affecting ocular health
- Is using any systemic or topical medications that will affect ocular health
- Has any ocular pathology or sever insufficiency of lacrimal secretion
- Has persistent, clinically significant corneal or conjunctival staining
- Has active neovascularization or any central corneal scars
- Is aphakic
- Is pregnant or lactating
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器:Bioclean MPS VII / comfilcon A combination
Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.
|
隐形眼镜
其他名称:
PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
|
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有源比较器:Aosept Clearcare / comfilcon A combination
Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.
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隐形眼镜
其他名称:
Hydrogen Peroxide Disinfecting and Cleaning system
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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 |
|---|---|---|
|
Ocular Health - Corneal Staining
大体时间:1 week
|
Corneal staining for Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination assessed by slit lamp.
Grade 0-4, 0=normal, 1=trace, 2=mild, 3=moderate, 4=severe.
|
1 week
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Comfort
大体时间:1 week
|
Subjective ratings of comfort scores for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear.
Scale 0-10, 0=very bad/poor, 10=very good/excellent.
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1 week
|
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Dryness
大体时间:1 week
|
Subjective ratings of dryness for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination were assessed at 1 week: after insertion, after 4 hours of wear, after 8 hours of wear, before removal, and after all day wear.
Scale 0-10, 0=very bad/poor, 10=very good/excellent.
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1 week
|
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Stinging and Burning Sensation
大体时间:Baseline
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Subjective ratings of stinging and burning sensation for Bioclean MPS VII / comfilcon A combination and Aosept Clearcare / comfilcon A combination.
Scale 0-10, 0=difficult to wear, 10=no sensation at all.
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Baseline
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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:Yuji Kodama, MD, PhD、Kodama Eye Clinic
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9月1日
初级完成 (实际的)
2015年10月1日
研究完成 (实际的)
2016年6月1日
研究注册日期
首次提交
2015年8月26日
首先提交符合 QC 标准的
2015年8月28日
首次发布 (估计)
2015年9月2日
研究记录更新
最后更新发布 (实际的)
2020年8月18日
上次提交的符合 QC 标准的更新
2020年8月4日
最后验证
2020年8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.