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Information to be gathered in survey format instead of a clinical investigation.
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The purpose of this post-market study is to gather long term performance and safety data on FreshLook® One-day Colors cosmetic contact lenses and DAILIES FreshLook® ILLUMINATE cosmetic contact lenses in participants 12 years of age and older.
FreshLook® One-day Colors contact lenses and DAILIES FreshLook® ILLUMINATE contact lenses do not contain visual correction and are worn for cosmetic purposes only. Eligible participants will receive the contact lens color of their choice (if available) to be used as intended by the manufacturer for the duration of the study, approximately 1 year. This study will be conducted in the United States and Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nelfilcon A plano cosmetic contact lenses | Other | Nelfilcon A plano cosmetic contact lenses worn in both eyes at least 5 hours per day, at least 2 days a week, for one year. The lenses will be worn in a daily wear, daily disposable modality. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nelfilcon A plano cosmetic contact lenses | Device | Commercially approved colored contact lenses worn to alter or enhance the apparent color of the eye. Plano contact lenses do not contain visual correction and are worn for cosmetic purposes only. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of corneal infiltrative events | A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. | Up to Year 1 |
| Incidence of microbial keratitis | Microbial keratitis is a sight-threatening infection of the cornea. | Up to Year 1 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Lead, Vision Care | Alcon Research, LLC | 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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