Dry Eye Disease Clinical Trial
Official title:
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Supportive Care
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