Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A
2012年6月8日 更新者：Alcon Research
Clinical Performance of a Marketed Silicone Hydrogel Contact Lens When Used With Silicone Hydrogel MPDS FID 114675A
The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
89
阶段
- 不适用
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:
- 18 years of age or older.
- History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
- Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
- Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
- Use of products other than a multi-purpose solution to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
- History of intolerance or known sensitivity to any component of the treatments.
- Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
- Other protocol-defined exclusion criteria may apply.
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：支持治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：FID 114576A / renu fresh
FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
|
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
其他名称：
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
其他名称：
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
其他名称：
|
|
其他：renu fresh / FID 114675A
Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
|
Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
其他名称：
Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
其他名称：
A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
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 |
|---|---|---|
|
Lens Fit
大体时间：Day 14 of lens wear
|
As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration.
Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable.
Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration.
A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.
|
Day 14 of lens wear
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score
大体时间：Day 14 of lens wear
|
The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye.
Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage.
The scores for the four regions were summed, with a sum score range of 0-16.
|
Day 14 of lens wear
|
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10月1日
初级完成 (实际的)
2011年2月1日
研究完成 (实际的)
2011年2月1日
研究注册日期
首次提交
2010年11月10日
首先提交符合 QC 标准的
2010年11月10日
首次发布 (估计)
2010年11月15日
研究记录更新
最后更新发布 (估计)
2012年7月12日
上次提交的符合 QC 标准的更新
2012年6月8日
最后验证
2012年6月1日
更多信息
与本研究相关的术语
其他研究编号
- C-10-030
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.