Cosmetic Contact Lenses Post-Market Clinical Follow-up Study

Not Applicable

Withdrawn

• Conditions: Cosmetic Appearance
• Interventions: Device: Nelfilcon A plano cosmetic contact lenses

• Registration Number: NCT06517316
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2024-07-18
• Study First Submitted QC: 2024-07-18
• Study First Posted: 2024-07-24
• Study Start: 2025-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 700

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 exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nelfilcon A plano cosmetic contact lenses	Nelfilcon A plano cosmetic contact lenses	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States