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

This study has been completed.
Sponsor:
Collaborator:
Allergan
Information provided by:
Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT00395759
First received: November 2, 2006
Last updated: October 21, 2007
Last verified: October 2007

November 2, 2006
October 21, 2007
September 2005
Not Provided
  • 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
  • Contrast sensitivity 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
Complete list of historical versions of study NCT00395759 on ClinicalTrials.gov Archive Site
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The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Supportive Care
Dry Eye Disease
Drug: Optiva artificial tear by Allergan
Not Provided
Thai LC, Tomlinson A, Ridder WH. Contact lens drying and visual performance: the vision cycle with contact lenses. Optom Vis Sci. 2002 Jun;79(6):381-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
September 2007
Not Provided

Inclusion Criteria:

  • 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 18. Best corrected visual acuities will be at least 20/25 on a standard Snellen acuity chart at distance.

Exclusion Criteria:

  • 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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00395759
SCCO2-2233
Not Provided
Not Provided
Southern California College of Optometry
Allergan
Principal Investigator: William Ridder, OD. PhD Southern California College of Optometry
Southern California College of Optometry
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP