Status:
WITHDRAWN
Cosmetic Contact Lenses Post-Market Clinical Follow-up Study
Lead Sponsor:
Alcon Research
Conditions:
Cosmetic Appearance
Eligibility:
All Genders
12+ years
Phase:
NA
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 ...
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 t...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 exclusion criteria may apply.
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06517316
Start Date
January 1 2025
End Date
March 1 2026
Last Update
June 12 2025
Active Locations (1)
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1
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134