Cosmetic Appearance
Conditions
Keywords
Eye color, Colored contact lenses
Brief summary
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.
Detailed description
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.
Interventions
DEVICENelfilcon A plano cosmetic contact lenses
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.
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Subject and/or parents/legally authorized representative must be able to understand and sign an approved informed consent form. * Has never worn contact lenses before, with or without refractive error correction. * Willing to wear cosmetic contact lenses and who have expressed interest in 1 to 3 color variants of nelfilcon A plano cosmetic contact lenses. * Willing to wear the study lenses at least 5 hours per day for at least 2 days a week during the study. * Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Any ocular disease or condition that would contraindicate contact lens wear. * Pregnant and lactating women. * Any use of systemic or ocular medications that would contraindicate contact lens wear. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of corneal infiltrative events | Up to Year 1 | A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea. |
| Incidence of microbial keratitis | Up to Year 1 | Microbial keratitis is a sight-threatening infection of the cornea. |
Countries
United States
Outcome results
None listed