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

Dry Eye Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00395759
• Other study ID #: SCCO2-2233
• Status: Completed
• Phase: N/A
• First received: November 2, 2006
• Last updated: October 21, 2007
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: October 2007
• Source: Southern California College of Optometry
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dry Eye Disease
• Eye Diseases

Intervention

Drug:
• Optiva artificial tear by Allergan

Locations

Country	Name	City	State
United States	Southern California College of Optometry	Fullerton	California

Sponsors (2)

Lead Sponsor	Collaborator
Southern California College of Optometry	Allergan

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Contrast sensitivity and optical aberrations before daily artificial tear use and at 1 and 2 weeks after daily use
Primary	Dry eye questionnaire before and at 1 and 2 weeks after artificial tear use
Primary	Slit lamp exam before and at 1 and 2 weeks after artificial tear use