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Sponsors and Collaborators: |
Southern California College of Optometry Alcon Research |
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Information provided by: | Southern California College of Optometry |
ClinicalTrials.gov Identifier: | NCT00560898 |
The purpose of this study is to measure the relative "barrier" function of the top layer of the cornea (called the epithelium), or the degree to which the cornea can prevent the penetration of the colored dye sodium fluorescein into the eye. This is a clinical investigation of the effect on corneal barrier function following wear of two contact lens materials and two contact lens care systems, approved for marketing in the US by the Food and Drug Administration. These contact lenses will be worn for two hours, following soak in one of two marketed contact lens disinfecting solutions. Approximately 25 young, adapted contact lens wearers will participate.
Condition | Intervention | Phase |
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Contact Lens Disinfecting Solutions |
Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Comparison of Two Multi-Purpose Solution and Contact Lens Material Combinations on Human Corneal Barrier Function |
Estimated Enrollment: | 25 |
Study Start Date: | September 2007 |
Study Completion Date: | March 2008 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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2: Experimental
contact lenses disinfected in multipurpose solution
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Drug: ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
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3: Experimental
contact lenses disinfected in multipurpose solution
|
Drug: Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
4: Experimental
contact lenses disinfected in multipurpose solution
|
Drug: Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
1: Experimental
contact lenses disinfected in multipurpose solution
|
Drug: ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution
Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours
|
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
At least 18 years of age.
Exclusion Criteria:
Subjects demonstrating any medical condition that may affect the results of this study SHOULD NOT be enrolled. The following are specific conditions that exclude subjects from enrollment in this study.
United States, California | |
Southern California College of Optometry | |
Fullerton, California, United States, 92831 |
Principal Investigator: | Jerry R Paugh, OD, PhD | Southern California College of Optometry |
Study ID Numbers: | 00001418, 00001418 |
Study First Received: | November 15, 2007 |
Last Updated: | May 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00560898 |
Health Authority: | United States: Institutional Review Board |
staining epithelial barrier function |