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The purpose of this study was to investigate the association of inflammatory mediators found in the tear film during the development and following the induction of contact lens solution-induced corneal staining.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contact lens wearers | Experimental | Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline. |
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| Non-lens wearers | No Intervention | Non-lens wearers completed one study visit and served as the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opti-Free RepleniSH | Device | Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Tear Protein Expression | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Corneal Staining | 1 day |
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Inclusion Criteria:
For non-lens wearers:
For contact lens wearers:
Exclusion Criteria:
For non-lens wearers and contact lens wearers:
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| Name | Affiliation | Role |
|---|---|---|
| Jami Kern | Alcon, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | 76134 | United States |
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| ReNu MultiPlus | Device | Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion. |
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| Balafilcon A | Device | Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours. |
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| Unisol 4 | Other | Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion. |
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