Cosmetic Contact Lenses Post-Market Clinical Follow-up Study

NCT06517316 | Withdrawn FDA Device

• 1 other identifier: CLS891-P001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cosmetic Appearance

Keywords

Eye color; Colored contact lenses

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

Device: Nelfilcon A plano cosmetic contact lenses

Interventions

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.

Also known as: FreshLook® One-day Colors, DAILIES FreshLook® ILLUMINATE

Nelfilcon A plano cosmetic contact lenses

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2024
• First Posted: July 24, 2024
• Study Start: January 1, 2025
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)