Contact Lenses for Visual Acuity

No longer recruiting at 3 trial locations

Overseen By Study Contact

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Johnson & Johnson Vision Care, Inc.

Must not be taking: Ocular medications

Disqualifiers: Pregnancy, Ocular infections, Autoimmune, others

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

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two types of daily disposable soft contact lenses: B+L Infuse spherical soft contact lenses and J&J ACUVUE OASYS 1-Day spherical soft contact lenses, to assess their impact on visual clarity. Participants will wear each lens type for a week to compare performance. The trial seeks individuals who regularly wear soft silicone hydrogel contact lenses and have stable vision correction needs. Ideal participants should have a prescription that remains unchanged and must wear their lenses for at least 6 hours a day, 5 days a week. As an unphased trial, this study offers participants the chance to contribute to research that could improve the comfort and effectiveness of contact lenses for all users.

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

The trial requires that you do not use any eye medications and do not have any eye infections. If you have any diseases or take medications that might interfere with contact lens wear, you may be excluded from the study. The protocol does not specify a general requirement to stop all medications, but it's best to discuss your specific situation with the study team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that B+L Infuse and J&J ACUVUE OASYS 1-Day soft contact lenses are generally well-tolerated. Some users of B+L Infuse lenses report morning discomfort, which may require disposal of the lenses. However, the risk of serious side effects remains low, particularly when lenses are not worn overnight.

J&J ACUVUE OASYS 1-Day lenses share a similar safety profile. Some users experience mild eye irritation or discomfort. Although rare, serious issues like eye sores can occur with any contact lens. Both types of lenses are designed for daytime use and should be discarded at the end of the day to minimize risks.

Overall, these lenses are considered safe when used as directed. Following care instructions is essential to minimize potential problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these contact lenses because they offer a fresh approach to improving visual acuity. Unlike traditional contact lenses, which might prioritize basic comfort and vision correction, the B+L Infuse and J&J ACUVUE OASYS 1-Day lenses are designed to enhance comfort with advanced moisture retention technologies. This means they can potentially be worn longer and more comfortably throughout the day. Additionally, these lenses are daily disposables, which can improve hygiene and reduce the risk of eye infections compared to lenses that require cleaning and storage.

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

This trial will compare B+L Infuse spherical soft contact lenses with J&J ACUVUE OASYS 1-Day spherical soft contact lenses. Studies have shown that B+L Infuse contact lenses can reduce dryness, enhancing comfort. They are designed to maintain eye moisture, ensuring clear vision throughout the day. Research indicates high satisfaction among users, likely due to their sustained comfort during extended wear.

For J&J ACUVUE OASYS 1-Day lenses, research highlights their HydraLuxe technology, which mimics natural tears to keep eyes moist and vision clear. These lenses are also known for maintaining comfort in dry conditions, ensuring clear vision all day. Both lens options in this trial aim to enhance vision and comfort, making them suitable for daily use. ^{6 7 8 9 10}

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 people aged 18-39 who regularly wear soft contact lenses and have a prescription between -1.00 D to -6.00 D in each eye with good visual acuity (20/25 or better). They must be willing to follow the study's instructions, not be pregnant or breastfeeding, and not have worn rigid lenses recently.

Inclusion Criteria

Appear able and willing to adhere to the instructions set forth in this clinical protocol

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

Habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable or daily disposable wear modality (minimum of 6 hours per day, for a minimum of 5 days per week during the past 30 days)

Exclusion Criteria

Have a history of strabismus or amblyopia

Be currently pregnant or lactating

Be currently wearing monovision or multifocal contact lenses

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants wear test and control lenses in a crossover design for 1 week each

3 weeks

Weekly visits for lens fitting and evaluation

Follow-up

Participants are monitored for visual acuity and lens fit after each wearing period

1 week per wear period

1 visit per week

What Are the Treatments Tested in This Trial?

Interventions

• B+L Infuse spherical soft contact lenses
• J&J ACUVUE OASYS 1-Day spherical soft contact lenses

Trial Overview The study compares two types of daily disposable soft contact lenses: J&J ACUVUE OASYS and B+L Infuse. Participants will try both in random order across three periods to assess which provides better visual acuity.

How Is the Trial Designed?

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

Eligible subjects will be randomized to the test/control/control sequence, to wear the test lens, the control lens, and the control lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.

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

Eligible subjects will be randomized to the control/test/test sequence, to wear the control lens, the test lens, and the test lens again for 1-week each in a daily disposable modality for at least 5 days per week and 6 hours per day.

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. patlynk.com patlynk.com/trial/NCT07174596

Contact Lenses for Visual Acuity Improvement This study aims to compare the effectiveness of two different brands of approved contact lenses in improving vision clarity ... B+L Infuse spherical soft contact ...

2. reviewofoptometry.com reviewofoptometry.com/CMSDocuments/2020/10/BLInsert.pdf

INFUSED FOR BALANCE data show that Bausch + Lomb INFUSE™ contact lenses provide exceptional patient satisfaction and help reduce symptoms of contact lens dryness. 8. Next ...

3. ecp.bauschcontactlenses.com ecp.bauschcontactlenses.com/products/infuse-one-day/

For Eye Care Professionals: Bausch + Lomb INFUSE® One-Day INFUSE One-Day contacts are designed to help maintain ocular surface homeostasis to aid in minimizing contact lens dryness.

4. ichgcp.net ichgcp.net/clinical-trials-registry/553053-evaluation-of-approved-contact-lenses

Clinical Trial: Comparing Daily Contact Lenses for Vision ... The study is specifically comparing Bausch + Lomb Infuse spherical soft contact lenses against Johnson & Johnson ACUVUE OASYS 1-Day spherical ...

5. info.abboptical.com info.abboptical.com/hubfs/Profit%20Advisor/Q4%202024/PA4Q24_final%20-%20BL.pdf?hsLang=en

from personal experience ... INFUSE® contact lenses and wore their trial lenses for ≥7 days (n=777). Survey results include patients who strongly agreed, agreed, or slightly agreed (on ...

6. pi.bausch.com pi.bausch.com/globalassets/pdf/PackageInserts/Vision-Care/lenses/INFUSE-Patient-Information.pdf

INFUSE Patient Information The Bausch + Lomb INFUSE® (kalifilcon A). One-Day Soft (Hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and ...

7. accessdata.fda.gov accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=17975526&pc=LPL

MAUDE Adverse Event Report: BAUSCH AND LOMB ... Sometimes lenses never feel right in the morning and i have to throw them away.A couple times lenses arrived without fluid and are unusable.

8. bauschcontactlenses.com bauschcontactlenses.com/faqs/

Bausch + Lomb Contact Lenses FAQ | Frequently Asked ... Clinical studies have shown that the risk of serious adverse reactions is increased when daily wear lenses are worn overnight. Do INFUSE® One-Day contacts have ...

9. pi.bausch.com pi.bausch.com/globalassets/pdf/PackageInserts/Vision-Care/lenses/INFUSE-PIFG.pdf

Infuse SVS / Multifocal / Astigmatism PIFG Ins / US / Internal ... Studies have shown that contact lens wearers who are smokers have a higher incidence of adverse reactions than nonsmokers. • If a patient experiences eye ...

10. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf17/P170035b.pdf

summary of safety and effectiveness data (ssed) All test results met the pre-established acceptance criteria. The testing performed on the Ultra (samfilcon A) extended wear soft contact lens ...