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Proclear 1-D Multifocal Nondispensing Study

2014年3月7日 更新者：CooperVision, Inc.
This study is designed to compare the relative performance related to subjective and objective vision between two multifocal soft contact lenses.

研究概览

地位

完全的

条件

干预/治疗

详细说明

The aim of this study was to compare the subjective and objective vision. of Proclear® 1-D Multifocal test lenses (MF) with +0.75D overcorrection of the distance lens power in the nondominant eye compared to the Air Optix® Aqua Multifocal (CIBA VISION) contact lenses in low, Medium and High Add presbyopic subjects (+1.25 to +2.50 inclusive).

研究类型

介入性

注册 (实际的)

49

阶段

  • 不适用

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

  • 美国
    • Indiana
      • Bloomington,、Indiana、美国、47405
        • Clinical Optics Research Lab, Indiana University,

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

40年 至 65年 (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:

  • Be between 40 and 65 years of age (inclusive)
  • Require a reading addition of +1.25 to +2.50D (inclusive)
  • Spherical distance CL or spectacle prescription between +3.00D and -5.00D(inclusive)
  • Spectacle cylinder less than or equal to 0.75D in both eyes.
  • Currently has a reading add correction in their spectacle or CL habitual correction (e.g. if myope, removes distance correction to read)
  • Normal binocularity (no amblyopia, no strabismus, no habitually uncorrected anisometropia ≥ 2.00D)
  • Have a minimum 2 weeks soft contact lens experience
  • Be able to wear the study lens (e.g. good fit is attained and acceptable subjective comfort and vision for the duration of the study)
  • Able to read, comprehend and sign an informed consent
  • Willing to comply with the wear and study visit schedule
  • Monocular best-corrected distance visual acuity ≥ 20/25 in each eye
  • No gas permeable contact lens wear for 1 month prior to the study

Exclusion Criteria:

To be eligible for the study, each candidate must not present with any of the following

  • Any active corneal infection, injury, inflammation, or ocular abnormality
  • Systemic or ocular allergies, which might interfere with contact lens wear
  • Systemic disease, which might interfere with contact lens wear
  • Ocular disease, which might interfere with contact lens wear
  • Pregnant or lactating
  • Strabismus/amblyopia
  • Habitually uncorrected anisometropia greater than or equal to 2.00 D
  • Subjects who have undergone corneal refractive surgery
  • Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear

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
有源比较器：omafilcon A / PC 1-D MF

omafilcon A (PC 1-D MF) / lotrafilcon B (AIR OPTIX MF)

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
设备：omafilcon A / PC 1-D MF
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
其他名称：
  • Proclear Multifocal daily wear soft contact lenses
设备：lotrafilcon B / Air Optix MF
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
其他名称：
  • Air OPtix Aqua Multifocal extended wear soft contact lenses
有源比较器：lotrafilcon B / Air Optix MF

lotrafilcon B (AIR OPTIX MF) / omafilcon A (PC 1-D MF)

Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
设备：omafilcon A / PC 1-D MF
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
其他名称：
  • Proclear Multifocal daily wear soft contact lenses
设备：lotrafilcon B / Air Optix MF
Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
其他名称：
  • Air OPtix Aqua Multifocal extended wear soft 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
Objective Vision Assessments: High Contrast Distance Visual Acuity
大体时间：After 1 hour of lens wear
Tested with charts distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
After 1 hour of lens wear
Objective Vision Assessments: High Contrast Intermediate Visual Acuity
大体时间：After 1 hour of lens wear
Tested with charts at intermediate distance (100cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
After 1 hour of lens wear
Objective Vision Assessments: High Contrast Near Visual Acuity
大体时间：After 1 hour of lens wear
Tested with charts set at near point (40cm)distant to the subject with both eyes together in normal lighting conditions. The unit of measure is logMAR units (logarithm of the minimum angle of resolution) A logMAR acuity of 0.0 equates to 20/20 Snellen acuity. Positive logMAR values indicate poorer vision and negative values denote better visual acuity than baseline 20/20 value.
After 1 hour of lens wear

次要结果测量

结果测量
措施说明
大体时间
Subjective Overall Vision: High Contrast Distance Visual Quality
大体时间：After 1 hour of lens wear
Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Intermediate Visual Quality
大体时间：After 1 hour of lens wear
Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
After 1 hour of lens wear
Subjective Vision Assessments: High Contrast Near Visual Quality
大体时间：After 1 hour of lens wear
Subjects instructed to rate Vision quality at distance, intermediate and near vision (OU) using a 0-100 numerical scale where 0 = poor and 100 = excellent.
After 1 hour 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。

赞助

CooperVision, Inc.

调查人员

  • 首席研究员：Peter Kollbaum, OD, PhD、Clinical Optics Research Lab, Indiana University, Bloomington, Indiana, USA

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

2012年2月1日

初级完成 (实际的)

2012年5月1日

研究完成 (实际的)

2012年5月1日

研究注册日期

首次提交

2012年2月2日

首先提交符合 QC 标准的

2012年2月2日

首次发布 (估计)

2012年2月6日

研究记录更新

最后更新发布 (估计)

2014年4月7日

上次提交的符合 QC 标准的更新

2014年3月7日

最后验证

2014年3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

  • CV-12-02A

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