Comparison of Two Multi-Purpose Solution and Lens Material Combinations on Corneal Barrier Function
Comparison of Two Multi-Purpose Solution and Contact Lens Material Combinations on Human Corneal Barrier Function
The purpose of this study is to measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye.
This is a clinical investigation of the effect on corneal barrier function following wear of two contact lens materials and two contact lens care systems, approved for marketing in the US by the Food and Drug Administration.
These contact lenses will be worn for two hours, following soak in one of two marketed contact lens disinfecting solutions.
Approximately 25 young, adapted contact lens wearers will participate.
研究概览
地位
完全的
干预/治疗
- 药品:ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution
- 药品:Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution
- 药品:Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution
- 药品:ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution
研究类型
介入性
注册 (预期的)
25
阶段
- 第四阶段
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
-
-
California
-
Fullerton、California、美国、92831
- Southern California College of Optometry
-
-
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 80年 (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.
- Understand your rights as a research subject and give written informed consent by signing the Informed Consent Form, Subject Bill of Rights, and Patient Authorization for Use and Release of Health and Research Study Information (HIPAA form).
- Be likely to finish the entire study, understand the study instructions, and be willing to follow the instructions.
- Contact lens prescription between +4.00 D to -9.00 D (spherical equivalent).
- Best correctable visual acuity of at least 20/40 in each eye.
- Willing to de-adapt (do not wear) from habitual contact lenses for periods of three days prior to barrier function determination.
- Possess a functional spectacle prescription to allow adequate vision during the de-adaptation and barrier function determination periods.
- No known ocular or systemic allergies, which may interfere with contact lens wear.
- No known systemic disease, or need for medication that may interfere with contact lens wear (i.e. antihistamines, beta-blockers, steroids).
Exclusion Criteria:
Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
- Eye (ocular) or systemic allergies that may interfere with contact lens wear.
- Less than one month successful, full time (defined as more than 8 hours per day, and more than 5 days per week) soft lens wear.
- Systemic disease or uses of medication, which may interfere with contact lens wear.
- Clinically significant corneal swelling (greater than grade 3 or 4 on a 0-4 scale), corneal blood vessel growth) (vascularization), corneal staining, bulbar redness, tarsal redness, or any other abnormality of the cornea that may cause unsafe contact lens wear.
- Any active ocular infection.
- Prior corneal refractive surgery (i.e., LASIK, PRK, etc).
- Have used medications within 24 hours of study entry or have an ongoing need to use ocular medication.
- Are taking part in any other study or have taken part in a study within the last 14 days
- Have a medical condition that your study eye doctor thinks may make it not appropriate for you to participate in this study.
- Are pregnant, or anticipate becoming pregnant during the course of this 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
- 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:2
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
|
实验性的:3
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
|
实验性的:4
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
|
实验性的:1
contact lenses disinfected in multipurpose solution
|
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Epithelial penetration rate of sodium fluoeescein, in nm/sec
大体时间:Immediately post measurement
|
Immediately post measurement
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Corneal staining
大体时间:Immediately following barrier determination
|
Immediately following barrier determination
|
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
2007年9月1日
初级完成 (实际的)
2007年12月1日
研究完成 (实际的)
2008年3月1日
研究注册日期
首次提交
2007年11月15日
首先提交符合 QC 标准的
2007年11月19日
首次发布 (估计)
2007年11月20日
研究记录更新
最后更新发布 (估计)
2008年5月20日
上次提交的符合 QC 标准的更新
2008年5月19日
最后验证
2008年5月1日
更多信息
与本研究相关的术语
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.