Cosmetic Contact Lenses for Visual Acuity

Overseen By Study Contact

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Vision Care, Inc.

Must not be taking: Chronic steroids

Disqualifiers: Pregnancy, Systemic diseases, Ocular surgery, others

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

Compensation: Varies

Number of Visits: 3

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special cosmetic contact lens to evaluate its effectiveness in improving vision. Participants will try two different lenses, including a test lens with a cosmetic pattern, to compare their effects on vision. This trial may suit individuals who currently wear soft contact lenses for at least six hours daily, have mild nearsightedness (between -1.00 and -6.00 in each eye), and can see well with glasses or contacts (20/25 vision or better). As an unphased trial, it offers participants the chance to explore innovative vision solutions and contribute to advancements in eye care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you use medications that interfere with contact lens wear, you might be excluded from participating.

What prior data suggests that these contact lenses are safe for visual acuity?

Research shows that 1-DAY ACUVUE® DEFINE® contact lenses effectively enhance eye color while maintaining clear vision. These lenses use LACREON® technology to keep eyes moist and comfortable throughout the day. Studies indicate that most users find these lenses comfortable and are satisfied with the improvement in eye color and vision.

No major reports of serious side effects or problems have emerged with these lenses. Their availability suggests they are safe, which is encouraging for anyone considering participation in a clinical trial for these lenses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these cosmetic contact lenses because they aim to enhance visual acuity while also offering an aesthetic boost. Unlike standard contact lenses, which typically prioritize vision correction alone, these lenses incorporate a cosmetic pattern that can enhance the appearance of the eyes. Additionally, the lenses feature LACREON® technology, which ensures that moisture is embedded within the lens, potentially providing a more comfortable wearing experience throughout the day. This dual focus on both vision improvement and cosmetic enhancement sets these lenses apart from traditional options.

What evidence suggests that this trial's treatments could be effective for visual acuity?

Research has shown that 1-DAY ACUVUE® DEFINE® contact lenses can enhance natural eye color while providing clear vision. These lenses highlight the limbal ring, the border between the colored part of the eye and the white part, making eyes appear more vibrant. Many users report improved vision alongside cosmetic benefits. The lenses use LACREON® technology to keep eyes moist and comfortable throughout the day. Studies confirm that these lenses effectively enhance eye appearance and maintain good vision. Participants in this trial will be randomized to wear either the 1-DAY ACUVUE® DEFINE® lenses or the etafilcon A with PVP with cosmetic pattern contact lenses. A washout period between wear periods will assess their effects on visual acuity and cosmetic appearance. ^{1 2 3 6 7}

Who Is on the Research Team?

Johnson & Johnson Vision Care, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Vision Care, Inc.

Are You a Good Fit for This Trial?

This trial is for individuals with good eye health who want to try out cosmetic contact lenses. Participants should be interested in enhancing their visual appearance without affecting their vision.

Inclusion Criteria

The subject's refractive cylinder must be less than or equal to 0.75 D (inclusive) in each eye

Have spherical best corrected visual acuity of 20/25 or better in each eye

Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form

Exclusion Criteria

I do not have severe eye problems that would prevent me from wearing contact lenses.

I don't have any diseases like Sjögren's, hepatitis, or HIV that could affect wearing contact lenses.

Be currently pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants undergo a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral crossover study to evaluate visual acuity with a 5-minute washout period between lens wear periods

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of ocular physiology and lens fit

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• 1-DAY ACUVUE® DEFINE® with LACREON®
• etafilcon A with PVP with cosmetic pattern contact lens

Trial Overview The study tests two types of cosmetic contact lenses: etafilcon A with PVP and FRESH Honey, against a known product, 1-DAY ACUVUE® DEFINE® with LACREON®, to see which provides better visual acuity.

How Is the Trial Designed?

Group I: Test Lens/Control Lens Experimental Treatment 2 Interventions

Eligible subjects will be randomized into the Test Lens/Control Lens sequence, to wear the Test Lens followed by the Control Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

Group II: Control Lens/Test Lens Experimental Treatment 2 Interventions

Eligible subjects will be randomized into the Control Lens/Test Lens sequence, to wear the Control Lens followed by the Test Lens in a bilateral fashion, with a washout period of 5-minutes between wear periods.

Who Is Running the Clinical Trial?

Johnson & Johnson Vision Care, Inc.

Lead Sponsor

Trials

224

Recruited

26,100+

Top Products

- ACUVUE® disposable contact lenses - TECNIS® intraocular lenses - LASIK vision correction systems

Joaquin Duato

Johnson & Johnson Vision Care, Inc.

Chief Executive Officer since 2022

MBA from ESADE, Master of International Management from Thunderbird School of Global Management

Dr. Jijo James, MD

Johnson & Johnson Vision Care, Inc.

Chief Medical Officer since 2014

MD from St. Johns Medical College, MPH from Columbia University

Citations

1. acuvue.com acuvue.com/en-us/acuvue-define-1-day/

1‐DAY ACUVUE ® DEFINE ® Contact Lenses 1-DAY ACUVUE® DEFINE® Contact Lenses are more than coloured contacts, they're eye-enhancing contact lenses. Find more info and get your free trial pair now.

2. jnjvisionpro.com jnjvisionpro.com/en-us/products/1-day-acuvue-define/

ACUVUE® DEFINE® contact lenses Explore 1-Day Acuvue Define lenses at Johnson & Johnson Vision Pro. Enhance natural eye color and offer crisp vision to patients with this top solution.

3. contacts.costco.com contacts.costco.com/products/1-day-acuvue-define-30-pack

1-DAY ACUVUE® DEFINE® 30-pack | Costco Contacts Online Our innovative new contact lenses enhance the natural beauty of the eye, adding natural-looking definition to the limbal ring.

4. walmartcontacts.com walmartcontacts.com/lens/1-day-acuvue-define-30pk

1-DAY ACUVUE DEFINE 30pk - Contact Lenses from ... This eye enhancing lens comes in three designs, made to blend seamlessly with the color of your eyes while giving you a look that is distinctively yours.

5. nextdaycontacts.com nextdaycontacts.com/contact-lenses/acuvue/1-day-acuvue-define-30-pack?srsltid=AfmBOopAMrK4EL1vePr7Zt8mQgqjDfn8z2blApldv0WSLXBwMSSK2Bgc

1-DAY ACUVUE® DEFINE®, 30 pack Patients can experience a color boost in five different designs, as 1-DAY ACUVUE® DEFINE enhances the eye's natural beauty by adding definition to the limbal ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11878419/

Experience of applying cosmetic Etafilcon A contact lens in ... 1-DAY ACUVUE ® DEFINE ® with Lacreon ® lens has promising satisfactory cosmetic outcomes along with visual enhancement in cases of microcornea.

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/64/NCT04534764/Prot_SAP_000.pdf

Clinical Study Protocol Johnson & Johnson Vision Care, Inc. Investigational Products: etafilcon A with PVP cosmetic lenses, 1-DAY ACUVUE® DEFINE®. Vivid style contact Lenses. Key Words: etafilcon A with PVP cosmetic ...