Cosmetic Contact Lenses for Appearance
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.12345Why 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.12456
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants wear AIR OPTIX™ COLORS (lotrafilcon B) plano cosmetic contact lenses for cosmetic purposes
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
1
Treatment groups
Experimental Treatment
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alcon Research
Lead Sponsor
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
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=3Lotrafilcon 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 ...
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 ...
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-nct06493383Lotrafilcon 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 ...
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 ...
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