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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00395759
First Posted: November 3, 2006
Last Update Posted: October 23, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Allergan
Information provided by:
Southern California College of Optometry
  Purpose
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.

Condition Intervention
Dry Eye Disease Drug: Optiva artificial tear by Allergan

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Supportive Care
Official Title: The Visual Effect of an Investigational Artificial Tear in the Tear Layer.

Resource links provided by NLM:


Further study details as provided by Southern California College of Optometry:

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

Estimated Enrollment: 30
Study Start Date: September 2005
Study Completion Date: September 2007
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00395759


Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Allergan
Investigators
Principal Investigator: William Ridder, OD. PhD Southern California College of Optometry
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00395759     History of Changes
Other Study ID Numbers: SCCO2-2233
First Submitted: November 2, 2006
First Posted: November 3, 2006
Last Update Posted: October 23, 2007
Last Verified: October 2007

Keywords provided by Southern California College of Optometry:
contrast sensitivity

Additional relevant MeSH terms:
Eye Diseases
Lubricant Eye Drops
Ophthalmic Solutions
Pharmaceutical Solutions