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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optiva artificial tear by Allergan
Sponsored by
Southern California College of Optometry at Marshall B. Ketchum University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dry Eye Disease focused on measuring contrast sensitivity

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Southern California College of Optometry

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 2, 2006
Last Updated
October 21, 2007
Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00395759
Brief Title
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
Official Title
The Visual Effect of an Investigational Artificial Tear in the Tear Layer.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Southern California College of Optometry at Marshall B. Ketchum University
Collaborators
Allergan

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
contrast sensitivity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
30 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Optiva artificial tear by Allergan
Primary Outcome Measure Information:
Title
Contrast sensitivity and optical aberrations before daily artificial tear use and at 1 and 2 weeks after daily use
Title
Dry eye questionnaire before and at 1 and 2 weeks after artificial tear use
Title
Slit lamp exam before and at 1 and 2 weeks after artificial tear use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Ridder, OD. PhD
Organizational Affiliation
Southern California College of Optometry at Marshall B. Ketchum University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Southern California College of Optometry
City
Fullerton
State/Province
California
ZIP/Postal Code
92831
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12086305
Citation
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. doi: 10.1097/00006324-200206000-00012.
Results Reference
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The Visual Effect of an Investigational Artificial Tear in the Tear Layer.

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