此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Silicone Hydrogel Contact Lens Clinical and Comfort Benefits With a Multi-Purpose Disinfecting Solution

2014年6月25日 更新者:Alcon Research
The purpose of this study was to compare lens comfort on Day 30 for Air Optix® lenses cared for with OPTI-FREE® PureMoist® (OFPM) Multi Purpose Disinfecting Solution (MPDS) compared to Acuvue® Oasys® lenses cared for with habitual MPDS.

研究概览

详细说明

Prior to the 30-day study period, subjects were fitted with study lenses in a masked manner and underwent a run-in period of 4-8 days to adjust to the randomized lenses.

研究类型

介入性

注册 (实际的)

387

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:

  • Sign informed consent.
  • Currently wearing weekly/monthly contact lenses on a daily wear basis, as specified in protocol.
  • Willing to wear contact lenses on a daily wear basis for the duration of the study.
  • Currently using a multi-purpose solution, as specified in protocol.
  • Vision correctable to 20/30 (Snellen) or better in each eye at distance at Visit 1.
  • Willing to follow the study procedures and visit schedule.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Currently wearing Air Optix, Acuvue Oasys, or Acuvue Advance brand of lenses.
  • Currently using any Opti-Free brand of multi-purpose solution.
  • Must wear contact lenses on an extended wear (overnight) basis during the study.
  • Known sensitivity or intolerance to POLYQUAD® or ALDOX preserved lens care products.
  • Monocular (only one eye with functional vision), fit with only one lens, or monovision modality of wear.
  • Use of additional lens care products other than a multi-purpose solution within 7 days prior to Visit 1.
  • Use of topical ocular over-the-counter (OTC) or prescribed topical ocular medications, with the exception of contact lens rewetting drops, within 7 days prior to Visit 1.
  • Any abnormal ocular condition observed during the Visit 1 slit-lamp examination.
  • Current or history of ocular infections (i.e., microbial keratitis, conjunctivitis) or severe inflammation (i.e., iritis, infiltrates) within the 6 months prior to Visit 1.
  • Ocular surgery within the 12 months prior to Visit 1.
  • Any systemic diseases at Visit 1 (including allergies, respiratory infections or colds) that affect the eye and could be exacerbated by use of contact lenses or contact lens solutions.
  • Participation in any clinical study within 30 days of 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: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:Air Optix/OFPM
Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
其他名称:
  • AIR OPTIX® AQUA
  • AIR OPTIX® AQUA 多焦点
  • AIR OPTIX® for Astigmatism
Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions
其他名称:
  • OPTI-FREE® PureMoist™
有源比较器:Acuvue Oasys/Habitual MPS
Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
其他名称:
  • ACUVUE® OASYS® with HYDRACLEAR® PLUS
  • ACUVUE® OASYS® for ASTIGMATISM with HYDRACLEAR® PLUS
  • ACUVUE® OASYS® for PRESBYOPIA with HYDRACLEAR® PLUS
Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions

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
Likert Scale Questionnaire Item: "I Can Comfortably Wear my Lenses"
大体时间:Day 30; after 4 hours of lens wear
Response of subject to a questionnaire item using a 5-point Likert scale, where 5=strongly agree and 1=strongly disagree.
Day 30; after 4 hours 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。

调查人员

  • 研究主任:Jessie Lemp, PhD、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4月1日

初级完成 (实际的)

2013年7月1日

研究完成 (实际的)

2013年7月1日

研究注册日期

首次提交

2013年3月8日

首先提交符合 QC 标准的

2013年3月8日

首次发布 (估计)

2013年3月12日

研究记录更新

最后更新发布 (估计)

2014年7月22日

上次提交的符合 QC 标准的更新

2014年6月25日

最后验证

2014年6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.

订阅