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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014