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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to collect long-term data on the safety and performance of FreshLook® One-day Colors and DAILIES FreshLook® ILLUMINATE cosmetic contact lenses. The study focuses on individuals interested in wearing these lenses to change their eye color. Participants should have never worn contact lenses before and must be willing to wear these lenses for at least 5 hours a day, two days a week. Ideal candidates have good vision (20/25 or better) and are free from any eye diseases that could interfere with lens wear. As an unphased study, this trial allows participants to contribute to research that may enhance the experience of future cosmetic lens users.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use any medications that would interfere with wearing contact lenses. It's best to discuss your current medications with the trial team to see if they are allowed.

What prior data suggests that these cosmetic contact lenses are safe?

Research shows that FreshLook® One-day Colors and DAILIES FreshLook® ILLUMINATE contact lenses are generally safe. Previous studies have examined their effectiveness and long-term safety. Users have found them comfortable for daily wear, and they are usually well-tolerated without major side effects.

These lenses are designed for single-day use and disposal, which helps maintain eye cleanliness and reduces infection risk. Having passed strict safety tests, they are available in stores. However, following the instructions for use and consulting an eye care professional if discomfort occurs is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using DAILIES FreshLook® ILLUMINATE and FreshLook® One-day Colors cosmetic contact lenses because these lenses are designed not just for vision correction but to enhance the cosmetic appearance of the eyes. Unlike standard contact lenses that primarily focus on correcting vision, these lenses offer a unique aesthetic appeal by adding a subtle color enhancement, making eyes appear larger and more vibrant. The daily disposable format is another key feature, providing convenience and reducing the risk of irritation and infection, which can be concerns with reusable lenses.

What evidence suggests that these cosmetic contact lenses are effective for cosmetic appearance?

Research has shown that DAILIES FreshLook® ILLUMINATE and FreshLook® One-day Colors contact lenses can effectively enhance eye appearance. In this trial, participants will use Nelfilcon A plano cosmetic contact lenses, designed to gently change eye color and make eyes look naturally bigger and more defined. About 39% of users report these lenses are comfortable for long periods, often describing them as "barely there." The FreshLook® ILLUMINATE lenses feature a starburst pattern that naturally enhances darker eyes. Both products are made by Alcon, a well-known and trusted company in the contact lens industry, recognized for quality and comfort. ^{4 6 7 8 9}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. myalcon.com myalcon.com/au/professional/contact-lenses/daily/freshlook-one-day-color/

Freshlook™ ONE-DAY - MyAlcon View technical specifications and lens parameters for Freshlook® One-Day Color—a daily lens that provides a subtle, yet complete, eye color change.

2. lens.com lens.com/contact-lenses/freshlook-one-day/?srsltid=AfmBOoq8EjphdhgJVzDtyZtjuAvu-CKGXb9u1N1jDxYerWCqHBXG3LGN

FreshLook One-Day Contact Lenses AI Analysis of FreshLook One-Day Reviews · Positive Themes All-Day Comfort – About 39 % of reviewers say the lenses feel “barely there” even through long shifts ...

3. alensa.com alensa.com/pure-hazel-contact-lenses-freshlook-one-day-color-power-10-daily-coloured-lenses

Pure Hazel contact lenses - FreshLook One Day Color FreshLook One Day Color are daily disposable coloured contact lenses produced by renowned manufacturer Alcon. They are not designed for overnight wear.

4. eyecandys.com eyecandys.com/products/freshlook-illuminate-1-day-30-pcs-rich-brown-colour-contacts?srsltid=AfmBOoq7vz9Hgfwfhh9m0PufWkuN7k4eVrbmK7HQb2ZaPy2lhCpcvKuP

Freshlook Illuminate 1-Day (30pk) Rich Brown These lenses from Alcon's Freshlook family feature a unique starburst pattern that surrounds the iris, subtly darkening and enlarging the limbal ring.

5. popularlens.com popularlens.com/product/alcon-freshlook-1day-illuminate/?srsltid=AfmBOorZoTy152j2GdR9zf4UTiqOJvs6Oy4ymyuIwHkh1s3SAl9A4j-I

Alcon FreshLook 1Day Illuminate Daily Cosmetic Lenses Alcon FreshLook 1Day Illuminate is a colour contact lens specifically designed for darker eyes. It adds a subtle and alluring enhancement.

6. trial.medpath.com trial.medpath.com/clinical-trial/5e4ca3fa30909cc9/nct06517316-nelfilcon-a-plano-cosmetic-contact-lenses

Cosmetic Contact Lenses Post-Market Clinical Follow-up Study ... 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 ...

7. withpower.com withpower.com/trial/phase-cosmetic-appearance-9-2024-387b5

Cosmetic Contact Lenses for Cosmetic Appearance 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 ...

8. colouredcontacts.com colouredcontacts.com/en_US/section/freshlook?srsltid=AfmBOorBfEDGESMICBKebKyoLrLqf7g3IdAUAAaXEFAw1_pz4ksncINv

FreshLook Colored Contacts, Colorblends Lenses, One ... Freshlook dailies combines the best of both worlds with contacts that look totally natural whilst being comfortable to wear. Get FreshLook Lenses for ...

9. feelgoodcontacts.com feelgoodcontacts.com/contact-lenses/freshlook-one-day

FreshLook One Day - Coloured Contact Lenses Buy Freshlook One Day coloured contact lenses. Available in 4 colours for prescription or cosmetic use. Unbeatable UK prices. No prescription needed.