A Study to Evaluate a Modified Contact Lens
2020年9月9日 更新者：Bausch & Lomb Incorporated
A Study to Evaluate the Product Performance of a Modified Contact Lens
This study is being conducted to evaluate the product performance of SofLens daily disposable contact lenses packaged in an investigational Test solution versus SofLens daily disposable contact lenses packaged in the currently marketed solution (Control), as it relates to comfort when worn by adapted soft contact lens wearers on a daily-wear basis.
研究概览
研究类型
介入性
注册 (实际的)
438
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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New York
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Rochester、New York、美国、14609
- Bausch & Lomb, Inc.
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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 40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:
- Subjects must be free of any anterior segment disorders.
- Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
- Subjects must be habitual wearers of daily disposable or planned replacement (at least every 3 months) soft contact lenses.
- Subjects must live/work in an urban environment at least 6 hours per day and for at least 4 days per week throughout the duration of the study.
- Subjects must be willing and able to wear the study lenses on a daily wear basis while in an urban environment.
- Subjects living/working in the urban environment must feel challenged by harsh, drying outdoor conditions (ie dust, pollution, smog).
- Subjects must feel that being in an urban environment has a negative effect on their lens wearing experience.
- Subjects must have access to an internet connection and be able to send and receive email.
Exclusion Criteria:
- Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Subjects with 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 using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects with an active ocular disease or who are using any ocular medication.
- Subjects with any grade 2 or greater finding during the slit lamp examination
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- Subjects who are allergic to any component in the study care products.
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：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：SofLens in investigational solution
Bausch + Lomb SofLens daily disposable contact lens packaged in an investigational storage solution.
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SofLens in investigational solution, worn on a daily disposable basis for 7 days.
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有源比较器：SofLens in currently marketed solution
SofLens daily disposable contact lens packaged in currently marketed storage solution.
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SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
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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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视力
大体时间：2周后随访
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通过最小分辨率角的距离高对比度对数 (logMAR) 评估视敏度。
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2周后随访
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Percentage of Eyes With > Grade 2 Slit Lamp Findings
大体时间：At 2 weeks follow up
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Graded slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding).
The outcome measure is any finding > grade 2, across abnormalities.
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At 2 weeks follow up
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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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Symptoms and Complaints
大体时间：At 2 weeks follow up
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Symptoms and complaints were assessed on a scale from 0 to 100, with 0 denoting the most unfavorable symptoms/complaints.
Symptoms/complaints were collected by eye from each participant and based on the participant's experience with the study lenses.
Symptoms/complaints parameters included the following: Burning/stinging upon insertion, Comfort upon insertion, Overall comfort, Comfort at end of day, Ease of handling/insertion, Ease of handling/removal, Dryness, Itchiness, Redness, Vision upon insertion, Vision, Vision in low light, Lens cleanness upon insertion, Lens cleanness upon removal, and Overall impression.
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At 2 weeks follow up
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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
2011年4月1日
初级完成 (实际的)
2011年6月1日
研究完成 (实际的)
2011年7月1日
研究注册日期
首次提交
2011年6月16日
首先提交符合 QC 标准的
2011年7月8日
首次发布 (估计)
2011年7月12日
研究记录更新
最后更新发布 (实际的)
2020年9月30日
上次提交的符合 QC 标准的更新
2020年9月9日
最后验证
2020年9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.