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临床试验/NCT00395759
NCT00395759已完成不适用

The Visual Effect of an Investigational Artificial Tear in the Tear Layer.

Southern California College of Optometry at Marshall B. Ketchum University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2005年9月1日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Contrast sensitivity and optical aberrations before daily artificial tear use and at 1 and 2 weeks after daily use

研究概览

简要总结

The purpose of this study is to investigate how the addition of a new artificial tear product when applied to the tear layer affects contrast sensitivity and optical aberrations over time. We will also determine if there are any adverse effects associated with drop instillation.

详细描述

Artificial tears are applied to the eye to treat a variety of eye conditions. These conditions typically are associated with dry eyes and include tear film deficiency due to ocular or systemic disease, lid resurfacing problems, and contact lens wear. The artificial tears are used to alleviate the dry eye symptoms. The administration of an artificial tear to the eye can disrupt the tear layer and this disruption could then result in a decrease in contrast sensitivity.1 - 6

Temporal changes in tear film structure (e.g., drying of the tear layer) can distort the optical wavefront as it passes through the tear layer and subsequently reduce contrast sensitivity.1 Theoretically, any substance applied to the tear layer that alters its structure could affect contrast sensitivity. Previous work in our lab has demonstrated that Refresh Liquigel when applied to the tear layer of non-contact and contact lens wearing subjects can decrease contrast sensitivity.4, 5, 7 In this study, we propose to examine the effects of a new investigational artificial tear on contrast sensitivity and optical aberrations for up to 30 minutes after administration into the tear layer of normal and dry eye subjects. A questionnaire will also be used to determine the opinions of the subjects concerning this new artificial tear.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Single

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Thirty subjects free from ocular pathology will be chosen. Ten of the subjects will have a normal tear layer, ten will have a mild dry eye, and ten will have a moderate/severe dry eye. All subjects will be over the age of
  • Best corrected visual acuities will be at least 20/25 on a standard Snellen acuity chart at distance.

排除标准

  • Subjects will be excluded from this project if they have, or during the course of the experiment they develop, an allergy to the eye drops used in this project.

结局指标

主要结局

Contrast sensitivity and optical aberrations before daily artificial tear use and at 1 and 2 weeks after daily use

Dry eye questionnaire before and at 1 and 2 weeks after artificial tear use

Slit lamp exam before and at 1 and 2 weeks after artificial tear use

次要结局

未报告次要终点

研究者

发起方
Southern California College of Optometry at Marshall B. Ketchum University
申办方类型
Other

研究点 (2)

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