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?

This trial evaluates the safety and effectiveness of AIR OPTIX™ COLORS cosmetic contact lenses when worn long-term. These lenses solely change eye color and do not enhance vision. Participants must have no prior experience with contact lenses and should be interested in wearing these lenses for at least 5 hours on 2 days each week. This trial suits individuals with good vision (able to see well without glasses) who wish to explore cosmetic lenses. As an unphased trial, it provides a unique opportunity for participants to try cosmetic lenses in a safe and monitored setting.

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

The trial does not specify if you need to stop taking your current medications, but it excludes those using medications that would interfere with wearing contact lenses. It's best to discuss your specific medications with the trial team.

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

Research has shown that lotrafilcon B plano cosmetic contact lenses, such as AIR OPTIX™ COLORS, are generally safe for use. These lenses are designed for daily wear. Alcon, the manufacturer, provides guidelines to ensure safe use, and following these instructions reduces any risks.

Lotrafilcon B lenses have FDA approval for vision correction in other contact lens types, indicating the material's safety. No specific reports of serious problems have emerged when these lenses are used as directed.

Always adhere to the cleaning and storage instructions provided by your eye care professional. This practice helps maintain eye health and lowers the risk of issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AIR OPTIX COLORS because these lenses offer a unique blend of comfort and cosmetic enhancement. Unlike typical corrective lenses, these are plano, meaning they don't alter vision but enhance appearance with vibrant colors. Made from Lotrafilcon B, a highly breathable silicone hydrogel, these lenses allow more oxygen to reach the eye, potentially increasing comfort for extended wear. Additionally, the monthly replacement schedule offers a balance between convenience and lens hygiene, which could improve user satisfaction compared to daily or bi-weekly alternatives.

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

AIR OPTIX™ COLORS contact lenses, used by participants in this trial, enhance natural eye color and come in twelve shades. A special material allows the eyes to breathe, ensuring daily comfort. Research has shown that these lenses are safe when used as directed, which involves wearing them for at least 5 hours a day, 2 days a week. Designed for cosmetic use only, they do not improve vision. Replace the lenses monthly and clean and store them properly to maintain eye health. Overall, these lenses offer a safe and comfortable option for long-term eye color change. ^{1 2 4 5 6}

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

Citations

1. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/K133176.pdf

Ciba Vision Corporation - accessdata.fda.gov AIR OPTIX® COLORS are daily wear soft contact lenses made of 33% water and 67% lotrafilcon B, with a cosmetic pattern, for correcting ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06493383?term=AREA%5BBasicSearch%5D(AREA%5BConditionSearch%5D(Cosmetic))&rank=3

Lotrafilcon B Plano Cosmetic Contact Lenses Study 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 ...

3. ctv.veeva.com ctv.veeva.com/study/lotrafilcon-b-plano-cosmetic-contact-lenses-study

Lotrafilcon B Plano Cosmetic Contact Lenses Study The purpose of this study is to gather long-term performance and safety data on AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses ...

4. myalcon.com myalcon.com/contact-lenses/colors/air-optix-colors/

AIR OPTIX® COLORS Monthly Color Contact Lenses - MyAlcon These Monthly Replacement Color Contact Lenses offer an admirable enhancement to your natural eye color with twelve shades to choose from.

5. app.trialscreen.org app.trialscreen.org/trials/lotrafilcon-b-plano-cosmetic-contact-lenses-trial-nct06493383

Lotrafilcon B Plano Cosmetic Contact Lenses Study * 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 ...

6. myalcon.com myalcon.com/professional/contact-lenses/monthly/air-optix-colors/

Air Optix® Colors Lens Parameters and Fitting Guide | Alcon US Important information for AIR OPTIX® COLORS (lotrafilcon B) contact lenses: For daily wear only for near/farsightedness. Contact lenses, even if worn for ...