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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
|Official Title:||The Visual Effect of an Investigational Artificial Tear in the Tear Layer.|
- 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
|Study Start Date:||September 2005|
|Study Completion Date:||September 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00395759
|United States, California|
|Southern California College of Optometry|
|Fullerton, California, United States, 92831|
|Principal Investigator:||William Ridder, OD. PhD||Southern California College of Optometry|