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| ID | Type | Description | Link |
|---|---|---|---|
| 00001418 |
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| Name | Class |
|---|---|
| Alcon Research | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2 | Experimental | contact lenses disinfected in multipurpose solution |
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| 3 | Experimental | contact lenses disinfected in multipurpose solution |
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| 4 | Experimental | contact lenses disinfected in multipurpose solution |
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| 1 | Experimental | contact lenses disinfected in multipurpose solution |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ProClear Lens Material soaked in ReNu Multiplus Multipurpose Solution | Drug | Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours |
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| Measure | Description | Time Frame |
|---|---|---|
| Epithelial penetration rate of sodium fluoeescein, in nm/sec | Immediately post measurement |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal staining | Immediately following barrier determination |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Jerry R Paugh, OD, PhD | Southern California College of Optometry at Marshall B. Ketchum University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California College of Optometry | Fullerton | California | 92831 | United States |
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| Acuvue Advance Lens Material soaked in ReNu Multiplus Multipurpose Solution | Drug | Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours |
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| Acuvue Advance Lens Material soaked in Optifree RepleniSH Multipurpose Solution | Drug | Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours |
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| ProClear Lens Material soaked in Optifree RepleniSH Multipurpose Solution | Drug | Contact lens soaked in multipuprpose solution for 8 hours, then worn for two hours |
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