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Effectiveness of a Marketed One-Step Peroxide Lens Care Solution in Symptomatic Contact Lens Wearers

2015年5月26日 更新者：Alcon Research
The purpose of this study is to assess improvement of palpebral roughness and associated symptoms with 3 months use of Clear Care®.

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

142

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:

  • Current biweekly or monthly silicone hydrogel contact lens wearer (excluding Air Optix® brand) and have worn these lenses bilaterally for at least three (3) months prior to Visit 1 (daily wear use only).
  • Symptoms of contact lens discomfort as defined by the protocol.
  • Habitual use of a biguanide-preserved multi-purpose solution for at least 30 days prior to Visit 1.
  • Mild to severe (grade 2-4) Investigator rated palpebral roughness in one or more zones of either eye.
  • Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

  • Extended (over-night) contact lens wearer.
  • Any systemic or ocular disease or disorder (refractive disorder allowed and mild dry eye with successful contact lens wear is permitted), complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study.
  • Topical ocular over the counter (OTC) or prescribed medications, with the exception of contact lens rewetting drops, within 7 days of enrollment.
  • Other protocol-specified 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：并行分配
  • 屏蔽：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：Clear Care
Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
设备：Hydrogen peroxide-based contact lens solution
其他名称：
  • 清除护理®
设备：Habitual contact lenses
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
有源比较器：Habitual MPS
Habitual contact lens solution used with habitual contact lenses for 90 days
设备：Habitual contact lenses
Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
设备：Habitual contact lens solution
Biguanide-preserved

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
Mean Change From Baseline in Investigator Rated Lid Papillae Maximum Score at Day 90
大体时间：Baseline (Day 0), Day 90
Lid papillae (bumps on the inner eyelid) were assessed by the investigator using slit-lamp biomicroscopy and classified independently for the four palpebral zones (upper lid=1-3; lower lid=4) on a 5-point forced choice scale, where 0 = None; 1 = Slight (diffuse papillae); 2 = Mild (diffuse & tufts papillae); 3 = Moderate (moderate & tufts papillae); 4 = Severe (giant papillae). The maximum of the four zones was selected for the analysis. Both eyes were included in the model for analysis. A higher change value indicates a larger reduction in the severity of the lid papillae.
Baseline (Day 0), Day 90

次要结果测量

结果测量
措施说明
大体时间
Top 2 Box Percentage Agreement for "My Lenses Feel Like New" at Day 90
大体时间：Day 90
As interpreted and reported by the subject on a questionnaire. A 5-point Likert scale was used, where 1=strongly disagree; 2=disagree; 3=undecided; 4=agree; 5=strongly agree. The Top-2-box response (agree, strongly agree) was calculated and reported as a percentage of all responses.
Day 90
Mean Frequency Score for Symptoms of Grittiness at Day 90
大体时间：Day 90
As interpreted and reported by the subject on a questionnaire. The subject was asked, "During a typical day in the past 2 weeks, how often did your eyes feel gritty and/or scratchy while wearing your contact lenses?" and responded on a 5-point scale (1 = Never; 2 = Rarely; 3 = Sometimes; 4 = Frequently; 5 = Constantly).
Day 90
Mean Frequency Score for Symptoms of Dryness at Day 90
大体时间：Day 90
As reported and interpreted by the subject on a questionnaire. The subject was asked "During a typical day in the past 2 weeks, how often did your eyes feel dry?" and responded on a 5-point scale ((0 = Never; 1 = Rarely; 2 = Sometimes; 3 = Frequently; 4 = Constantly).
Day 90

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。

赞助

Alcon Research

调查人员

  • 研究主任：Lisa Zoota, MPH、Alcon Research

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

2013年12月1日

初级完成 (实际的)

2014年5月1日

研究完成 (实际的)

2014年5月1日

研究注册日期

首次提交

2013年11月18日

首先提交符合 QC 标准的

2013年11月22日

首次发布 (估计)

2013年11月27日

研究记录更新

最后更新发布 (估计)

2015年6月8日

上次提交的符合 QC 标准的更新

2015年5月26日

最后验证

2015年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A01337

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.

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