Cosmetic Contact Lenses for 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: 1 year

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to gather long-term performance and safety data on AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses in subjects 12 years of age and older. AIR OPTIX™ COLORS plano contact lenses do not contain visual correction and are worn for cosmetic purposes only.

Who Is on the Research Team?

Clinical Trial Lead, Vision Care

Principal Investigator

Alcon Research, LLC

Are You a Good Fit for This Trial?

This trial is for individuals aged 12 and older who want to enhance their cosmetic appearance using AIR OPTIX™ COLORS plano contact lenses, which are colored lenses without vision correction. Specific eligibility criteria details were not provided.

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

Best Corrected Visual Acuity (BCVA) of 20/25 or better in each eye at screening

Exclusion Criteria

Other protocol-defined exclusion criteria may apply

Pregnant and lactating women

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants wear AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses for cosmetic purposes

1 year

Monthly visits for lens replacement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lotrafilcon B Plano Cosmetic Contact Lenses

Trial Overview The study is evaluating the long-term performance and safety of AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses, which are used solely for changing eye color or enhancing appearance.

How Is the Trial Designed?

Group I: AIR OPTIX COLORS Experimental Treatment 1 Intervention

Lotrafilcon B plano cosmetic contact lenses worn in both eyes at least 5 hours per day, at least 2 days a week, for one year. Lenses will be replaced monthly and cleaned, rinsed, disinfected, and stored in accordance with the package labeling of the lens care products recommended by the eye care professional.

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