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Corneal Barrier Function With Multi-Purpose Solutions

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Southern California College of Optometry
ClinicalTrials.gov Identifier:
NCT00407238
First received: November 17, 2006
Last updated: October 21, 2007
Last verified: October 2007
History of Changes
  Purpose

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 Intervention
Contact Lens Care
 Device: Multi-purpose solutions (polyquaternium-1 and PHMB)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Comparison of Human Corneal Barrier Function With Three Marketed Multi-Purpose Solutions

Resource links provided by NLM:

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

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

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

Secondary Outcome Measures:
  • Corneal fluorescein staining

Estimated Enrollment: 25
Study Start Date: November 2006
Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00407238     History of Changes
Other Study ID Numbers: 6-08
Study First Received: November 17, 2006
Last Updated: October 21, 2007
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 22, 2013