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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

Brief Summary

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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

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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.

Conditions

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Dry Eye Disease

Keywords

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contrast sensitivity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Interventions

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Optiva artificial tear by Allergan

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Principal Investigators

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William Ridder, OD. PhD

Role: PRINCIPAL_INVESTIGATOR

Southern California College of Optometry at Marshall B. Ketchum University

Locations

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Southern California College of Optometry

Fullerton, California, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 12086305 (View on PubMed)

Other Identifiers

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SCCO2-2233

Identifier Type: -

Identifier Source: org_study_id