Cosmetic Contact Lenses for Cosmetic Appearance

Overseen By Alcon Call Center

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Alcon Research

Must not be taking: Systemic medications

Disqualifiers: Ocular disease, Pregnant, Lactating, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 52 weeks

Trial Summary

What is the purpose of this trial?

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.

Research Team

Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Eligibility Criteria

This trial is for individuals aged 12 and older who are interested in the long-term performance and safety of FreshLook® One-day Colors and DAILIES FreshLook® ILLUMINATE cosmetic contact lenses. Specific eligibility criteria were not provided.

Inclusion Criteria

Has never worn contact lenses before, with or without refractive error correction

I am willing to wear colored contact lenses and am interested in trying 1 to 3 colors.

I am willing to wear the study lenses for 5 hours a day, 2 days a week.

Exclusion Criteria

I am currently pregnant or breastfeeding.

I do not have any eye conditions that prevent me from wearing contact lenses.

Other protocol-defined exclusion criteria may apply

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear Nelfilcon A plano cosmetic contact lenses for cosmetic purposes, at least 5 hours per day, at least 2 days a week, for one year

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• DAILIES FreshLook® ILLUMINATE cosmetic contact lenses
• FreshLook® One-day Colors cosmetic contact lenses

Trial Overview The study is testing the long-term use of Nelfilcon A plano cosmetic contact lenses, specifically FreshLook® One-day Colors and DAILIES FreshLook® ILLUMINATE, to assess their performance and safety over time.

Participant Groups

Group I: Nelfilcon A plano cosmetic contact lenses Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Alcon Research

Lead Sponsor

Trials

739

Recruited

128,000+

Raquel C. Bono

Alcon Research

Chief Medical Officer since 2022

MD from Harvard Medical School

David Endicott

Alcon Research

Chief Executive Officer since 2018

MBA from University of Southern California