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The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FID 107027 | Experimental | Contact lens solution used as instructed for 90 days. |
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| ReNu MultiPlus | Active Comparator | Contact lens solution used as instructed for 90 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FID 107027 Multi-Purpose Disinfecting Solution | Device | Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses. |
| Measure | Description | Time Frame |
|---|---|---|
| Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses | Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Lens Wearing Time | Day 90 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Napier | Alcon Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elkin | Elkin | North Carolina | 28621 | United States |
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| ReNu MultiPlus Multi-Purpose Solution No Rub Formula | Device | Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses. |
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