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

53 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single visit, single-masked, non-dispensing, randomized, controlled, 2×2 bilateral crossover study to evaluate visual acuity.

Research Team

Johnson & Johnson Vision Care, Inc. Clinical Trial

Principal Investigator

Johnson & Johnson Vision Care, Inc.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Master’s from Thunderbird School of Global Management, MBA from ESADE

Dr. Raj Rajpal

Johnson & Johnson Vision Care, Inc.

Chief Medical Officer since 2023

MD