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Corneal Barrier Function With Multi-Purpose Solutions

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ClinicalTrials.gov Identifier: NCT00407238
Recruitment Status : Completed
First Posted : December 4, 2006
Last Update Posted : October 23, 2007
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Southern California College of Optometry

Brief Summary:
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Condition or disease Intervention/treatment Phase
Contact Lens Care Device: Multi-purpose solutions (polyquaternium-1 and PHMB) Not Applicable

Detailed Description:
The purpose of this study is to evaluate the effect on epithelial barrier function of three emarketed multi-purpose solution applied to the human eye with hydrogel lenses as during normal regimen use.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Comparison of Human Corneal Barrier Function With Three Marketed Multi-Purpose Solutions
Study Start Date : November 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear
U.S. FDA Resources




Primary Outcome Measures :
  1. Ratio of fluorescein dye penetration rate of test eye vs. control

Secondary Outcome Measures :
  1. Corneal fluorescein staining


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adapted daily soft contact lens wearers, at least 18 years of age, vision correctable to 20/40

Exclusion Criteria:

  • Ocular or systemic allergies, abnormalities of the cornea, active ocular infection, prior keratorefractive surgery, use of ocular medications

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): NCT00407238


Locations
United States, California
Southern California College of Optometry
Fullerton, California, United States, 92831
Sponsors and Collaborators
Southern California College of Optometry
Alcon Research
Investigators
Principal Investigator: Jerry R Paugh, OD, PhD Southern California College of Optometry

ClinicalTrials.gov Identifier: NCT00407238     History of Changes
Other Study ID Numbers: 6-08
First Posted: December 4, 2006    Key Record Dates
Last Update Posted: October 23, 2007
Last Verified: October 2007

Keywords provided by Southern California College of Optometry:
barrier function, multi-purpose solutions, silicone hydrogel contact lenses

Additional relevant MeSH terms:
Pharmaceutical Solutions