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。

Daily Wear Corneal Infiltrative Event Study (DWCIE)

2014年1月27日 更新者:Loretta Szczotka-Flynn、University Hospitals Cleveland Medical Center

Infiltrative Events During Silicone Hydrogel Daily Contact Lens (Daily Wear Corneal Infiltrative Event (DWCIE) Study)

This DWCIE Study is a prospective cohort study of patients fit to the FDA approved and marketed lotrafilcon A (Ciba Vision, Air Optix Night & Day Aqua) soft contact lenses for daily wear (DW) with monthly disposal. 218 healthy myopic (nearsighted) or hyperopic (farsighted) patients with minimal or no astigmatism and no contraindications to DW lens use will be followed for 1 year. The primary outcome is the risk of development of a corneal inflammatory event (CIE) as defined by slit lamp findings and patient symptoms. The main exposure of interest is microbial contamination of study lenses.

研究概览

研究类型

介入性

注册 (实际的)

218

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

    • Ohio
      • Cleveland、Ohio、美国、44106
        • Department of Ophthalmology University Hospitals Case Medical Center

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

15年 及以上 (孩子、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:

  1. The patient must be at least 15 years old.
  2. The patient must be free of any anterior segment disorders.
  3. The patient must have a spectacle corrected spherical refractive error between +5.50 D and -11.00 D with less than or equal to 1.00 D refractive cylinder.
  4. The patient must be correctable to 20/25 or better with spectacles.
  5. Flat and steep corneal curvatures from Simulated Keratometry readings must be between 39.00 and 48.00 D.
  6. Can be successfully fit with lotrafilcon A lenses at the enrollment visit.

Exclusion Criteria

  1. The patient has worn rigid gas permeable lenses within the last 30 days or polymethylmethacrylate lenses within the last 3 months.
  2. The patient must not be a current successful daily wear user of lotrafilcon A lenses. They may have tried lotrafilcon A lenses in the past, but must not have successfully worn these lenses for daily wear within the last 12 months.
  3. The patient has an autoimmune disease (except for Hashimoto's Thyroiditis), immunocompromising disease, connective tissue disease, atopic dermatitis, insulin dependent diabetes, or any other systemic disease that in the investigator's opinion will affect ocular health.
  4. The patient is taking chronic systemic medications such as corticosteroids, antimetabolites, or non-steroidal anti-inflammatory agents or any other medication that in the investigator's opinion will affect ocular physiology or study participation.
  5. The patient has any ocular disease or condition such as aphakia, corneal dystrophies, corneal edema, external ocular infection, iritis, or had any anterior segment surgery.
  6. The patient is taking any ocular medications. If a patient was previously taking any ocular medications, the medications must have been discontinued at least 2 weeks prior to enrollment.
  7. The patient must have less than or equal to grade 2 on any of the slit lamp observations of: upper tarsal papilla, corneal staining, corneal neovascularization, conjunctival injection, and lid erythema or scales. Slit lamp findings higher than grade 2 bias the patient toward an adverse event and it may be difficult to detect true change related to contact lens use.
  8. The patient is pregnant.

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:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
有源比较器:ReNu Multiplus and lotrafilcon A lenses
ReNu Multiplus contact lens care solution
FDA approved soft contact lenses
其他名称:
  • Air Optix Night & Day Aqua contact lenses
有源比较器:Clear Care solution and lotrafilcon A lenses
Clear Care Contact Lens Care Solution
FDA approved soft contact lenses
其他名称:
  • Air Optix Night & Day Aqua contact lenses

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
Number of Participants Developing a Corneal Inflammatory Event (CIE)
大体时间:up to 1 year
Raw number of participants in each solution arm developing CIE over 12 month follow-up period
up to 1 year

次要结果测量

结果测量
措施说明
大体时间
Number of Participants With CIE Stratified by Microbial Bioburden on Lenses
大体时间:up to 1 year
Microbial bioburden on lenses was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lenses
up to 1 year
Number of Participants With CIE Based Stratified by Presence or Absence of Corneal Staining Induced by Solution Use.
大体时间:up to 1 year
Presumed solution induced corneal staining was defined as diffuse punctate fluorescein staining of at least 15% surface area in at least 4 of 5 zones
up to 1 year
Number of Participants With CIE Stratified by Microbial Bioburden on Lens Cases
大体时间:up to 1 year
Microbial bioburden within lens storage cases was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora
up to 1 year
Number of Participants With CIE Stratified by Overall Microbial Bioburden on Lid Margins
大体时间:up to 1 year
Microbial bioburden on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal flora or presence of pathogenic abnormal flora on lids
up to 1 year
Number of Participants With CIE Stratified by CNS Microbial Bioburden on Lid Margins
大体时间:up to 1 year
Microbial bioburden with coagulase negative staphylococci (CNS) on lid margins was determined with predetermined cutoffs to identify substantial bioburden as high levels of normal CNS flora on lids
up to 1 year

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。

合作者

调查人员

  • 首席研究员:Loretta Szczotka-Flynn, OD, PhD、University Hospitals Cleveland Medical Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2009年11月1日

初级完成 (实际的)

2012年2月1日

研究完成 (实际的)

2012年2月1日

研究注册日期

首次提交

2009年7月9日

首先提交符合 QC 标准的

2009年7月9日

首次发布 (估计)

2009年7月10日

研究记录更新

最后更新发布 (估计)

2014年3月10日

上次提交的符合 QC 标准的更新

2014年1月27日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 001 (Marta Eliza Miller Foundation)

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