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The purpose of this study is to assess corneal staining and to measure the relative corneal epithelial "barrier" function (the degree to which the cornea can prevent penetration of colored sodium fluorescein dye into the eye) after 8 hours of wear with a known soft contact lens and multipurpose lens care solution combination.
This investigation will evaluate corneal staining and epithelial barrier function after eight hours of contact lens wear, which is past the peak staining time and more typical of daily lens wear time. A silicone hydrogel lens and multipurpose solution combination shown to induce significant corneal staining ( e.g. equivalent Grade 3 out of Grade 4 scale) will be used to evaluate potential corneal compromise. The study will be a prospective, single-center, double-masked, contralateral, daily wear investigation in adapted soft contact lens wearers. After a three day washout period (without lens wear, lenses will then be worn on one day for eight hours. Corneal staining and barrier function will be determined for a regimen and a saline control situation for each subject. Staining will be graded using the Efron Grading Scale, and permeability data will be estimated as the fluorescein penetration rate, Pdc in nm/sec for the test and control condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test eye | Experimental | Uses ReNu Multiplus as multipurpose soaking solution |
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| Control | Active Comparator | A new lens (PureVision) is soaked for 2 hours in non-preserved saline |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ReNu Multiplus multipurpose disinfecting solution | Device | A new lens (PureVision) soaked 6 hours to overnight in ReNu Multiplus |
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| Measure | Description | Time Frame |
|---|---|---|
| The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes. | The fluorescein dye diffusion rate in nanometers per second, is a diffusion rate into the corneal tissue. The fluorescein dye diffuses from the tears, where it is in high concentration, into the cornea, where it is in low concentration. It's diffusion is limited (or not) by the barrier properties and health of the epithelium. | After eight hours of wear |
| Permeability Rate, nm/Sec | A penetration rate, in nm/sec | After eight hours of wear |
| Measure | Description | Time Frame |
|---|---|---|
| The Secondary Outcome Measure Will be the Corneal Staining Grade, Compared Between the Test and Control Eye, as Well as Between the Baseline and Final Staining for Each Eye. | Corneal staining represents corneal abrasion or damage. It is graded by us on a 0 - 4 scale (4 being worst) in five corneal sectors. The total score per cornea or eye is thus graded on a 0 - 20 total scale. | After eight hours of wear |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jerry R Paugh, OD, PhD | Southern California College of Optometry at Marshall B. Ketchum University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southern California Colege of Optometry | Fullerton | California | 92831 | United States |
Eyes were randomized to one of two conditions.
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| ID | Title | Description |
|---|---|---|
| FG000 | Test Eye | A new PureVision contact lens is soaked in ReNu Multiplus disinfecting solution and worn for 8 hours |
| FG001 | Control | A new PureVision contact lens is soaked in non-preserved saline and worn for 8 hours |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Control | Device | A new lens (PureVision) is soaked for two hours in non-preserved saline |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | A new lens (PureVision) is soaked in ReNu Multiplus multipurpose soaking solution A new lens (PureVision) is soaked for 2 hours in non-preserved saline |
| Units | Counts |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Permeability Rate, Pdc | Diffusion rate in nanometers per second | Mean | Standard Deviation | nanometers per second |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Outcome Measure Will be Corneal Epithelial Dye Diffusion Rate in Nanometers Per Second, for the Test and Control Eyes. | The fluorescein dye diffusion rate in nanometers per second, is a diffusion rate into the corneal tissue. The fluorescein dye diffuses from the tears, where it is in high concentration, into the cornea, where it is in low concentration. It's diffusion is limited (or not) by the barrier properties and health of the epithelium. | Analysis was per protocol. | Posted | Mean | Standard Deviation | nanometers per second | After eight hours of wear | eyes | eyes |
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| Primary | Permeability Rate, nm/Sec | A penetration rate, in nm/sec | Posted | Mean | Standard Deviation | nm/sec | After eight hours of wear | eyes | eyes |
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| Secondary | The Secondary Outcome Measure Will be the Corneal Staining Grade, Compared Between the Test and Control Eye, as Well as Between the Baseline and Final Staining for Each Eye. | Corneal staining represents corneal abrasion or damage. It is graded by us on a 0 - 4 scale (4 being worst) in five corneal sectors. The total score per cornea or eye is thus graded on a 0 - 20 total scale. | Posted | Mean | Standard Deviation | score on a scale | After eight hours of wear | eyes | eyes |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Test Eye | Uses ReNu Multiplus as multipurpose soaking solution | 0 | 30 | 0 | 30 | ||
| EG001 | Control | A new lens (PureVision) is soaked for 2 hours in non-preserved saline | 0 | 30 | 0 | 30 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jerry R. Paugh, OD, PhD | Southern California College of Optometry | 714-449-7487 | jpaugh@scco.edu |
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