Safety Evaluation of a New Preservative in a Lubricating Eye Drop
2011年9月13日 更新者：Johnson & Johnson Consumer and Personal Products Worldwide
A Single-Center Study Evaluating the Safety of a New Preservative in an OTC Lubricant Eye Drop Used QID in Healthy Adults and in Subjects Diagnosed With Dry Eye
This study is to evaluate the safety of a new preservative in a lubricant eye drop used four times a day in healthy adults and subjects diagnosed with dry eye.
研究概览
详细说明
Single-site, open-labeled study.
Twenty two subjects will be enrolled into the healthy adult group and twenty two subjects into the dry eye group.
Each subject will be in the study for approximately 2 weeks (treatment) and seen at three study Visits: Visit 1 (Day 0, Baseline), Visit 2 (Day 7 +/- 1) and Visit 3 (Day 14 +/- 1).
Dosing regimen is 1-2 drops into each eye, four times daily, for two weeks.
Assessments will be comprised of visual acuity, slit lamp biomicroscopy, fluorescein corneal staining, and product comfort.
研究类型
介入性
注册 (实际的)
44
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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Massachusetts
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Andover、Massachusetts、美国、01810
- ORA, 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 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- At least 18 years of age
- Able to follow all study instructions and attend all required study visits
- Provide written informed consent
- Visual health and eye comfort within protocol-specified parameters
- Women of child-bearing potential must have a negative urine pregnancy test at screening, not be breast-feeding, and agree to use a protocol-specified acceptable form of birth control throughout the study
Exclusion Criteria:
- Any medical condition or history, or ocular scores, or use of any drug, device or medication that, per protocol or in the opinion of the investigator, might compromise the safety of the subject or analysis of the study results.
- Use of contact lenses outside protocol allowance
- Self-reported pregnancy, positive urine pregnancy test, breast-feeding; intends to become pregnant or breast-feed during the duration of the study, refuses protocol-specified urine pregnancy testing, and/or does not use protocol-specified birth control methods and agree to continue doing so for the duration of the study.
- Participated in an investigational drug or device trial within 30 days of entering the study.
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
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Healthy Subjects
Healthy Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.
|
Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
其他名称：
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实验性的：Dry-Eye Subjects
Dry-Eye Subjects instill 1-2 drops of the experimental eye drops into each eye four times per day for two weeks.
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Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
其他名称：
|
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 |
|---|---|---|
|
Post-dose Product Comfort
大体时间：baseline, Within Two weeks
|
Product (ocular) comfort was assessed for each eye immediately, and at 1, 2, and 3 minutes following dosing at Visit 1 and 3 using a scale ranging from 0 to 10, where 0 is very uncomfortable and 10 is very comfortable.
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baseline, Within Two weeks
|
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Change from Baseline in Pre-Dose Visual Acuity
大体时间：baseline, Within Two weeks
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Change from Baseline in Pre-Treatment Means of Pre-Dose Visual Acuity on the LogMAR scale.
(The LogMAR scale converts the geometric sequence of a traditional chart to a linear scale.
It measures visual acuity loss; positive values indicate vision loss, while negative values denote normal or better visual acuity.)
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baseline, Within Two weeks
|
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Change from Baseline in Pre-dose Inferior Staining
大体时间：baseline, Within Two weeks
|
Means and Differences from Visit 1 in Pre-Dose Inferior Staining
|
baseline, Within Two weeks
|
|
Change from Baseline in Mean Corneal Staining
大体时间：baseline, Within Two Weeks
|
Mean Corneal Staining averaging over the 5 corneal regions and averaging over both eyes (NEI scale 0-3)
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baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Central Staining
大体时间：baseline, Within Two Weeks
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Pre-dose Central Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Superior Staining
大体时间：baseline, Within Two Weeks
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Pre-Dose Superior Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Temporal Staining
大体时间：baseline, Within Two Weeks
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Pre-dose Temporal Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Nasal Staining
大体时间：baseline, Within Two Weeks
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Pre-dose Nasal Staining: Means and Differences from Visit 1
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baseline, Within Two Weeks
|
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Change from Baseline in Pre-Dose Average Staining
大体时间：baseline, Within Two Weeks
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Pre-dose Average Staining: Means and Differences from Visit 1
|
baseline, Within Two Weeks
|
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Changes in Slit-Lamp Findings: Eye Structure: Lid
大体时间：Within Two Weeks
|
Slit-lamp findings were recorded for the Lid ocular structure at 6 time points
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Within Two Weeks
|
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Changes in Slit-Lamp Findings: Eye Structure: Lens
大体时间：baseline, Within Two Weeks
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Slit-lamp findings were recorded for the Lens ocular structure at 6 time points
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baseline, Within Two Weeks
|
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Changes in Slit-Lamp Findings: Eye Structure: Conjunctiva
大体时间：baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Conjunctiva ocular structure at 6 time points
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baseline, Within Two Weeks
|
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Change from Baseline in Slit-Lamp Findings: Eye Structure: Cornea
大体时间：baseline, Within Two Weeks
|
Slit-lamp findings were recorded for the Cornea ocular structure at 6 time points
|
baseline, Within Two Weeks
|
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
- 研究主任：Sherryl Frisch、Johnson & Johnson Consumer and Personal Products Worldwide
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4月1日
研究完成 (实际的)
2011年4月1日
研究注册日期
首次提交
2011年9月13日
首先提交符合 QC 标准的
2011年9月13日
首次发布 (估计)
2011年9月14日
研究记录更新
最后更新发布 (估计)
2011年9月14日
上次提交的符合 QC 标准的更新
2011年9月13日
最后验证
2011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.