AzTrials
AzTrials

Visual AcuityNCT07174596

Evaluation of Approved Contact Lenses

A study testing B+L Infuse spherical soft contact lenses and J&J ACUVUE OASYS 1-Day spherical soft contact lenses in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
B+L Infuse spherical soft contact lenses and J&J ACUVUE OASYS 1-Day spherical soft contact lenses
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
4 sitesUnited States
Study dates
11 Sep 2025to 27 Oct 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

  1. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  2. Be between 18 and 39 (inclusive) years of age at the time of screening. 4. By self-report, habitually wear spherical soft silicone hydrogel contact lenses in both eyes in a daily reusable or daily disposable wear modality (i.e. not extended wear modality). Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the past 30 days.
  3. Have a habitual contact lens prescription that is current (no power change needed) within the prior 6 months, and they must have worn that prescription for at least 2 weeks prior to entering the study.
  4. Possess a wearable pair of spectacles that provide correction for distance vision.
  5. The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye.
  6. The best corrected, monocular, distance visual acuity must be 20/25 or better in each eye.

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Be currently pregnant or lactating.
  2. Be currently using any ocular medications or have any ocular infection of any type.
  3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus [HIV]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See Section 9.1 for additional details regarding excluded systemic medications.
  4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
  5. Be currently wearing monovision or multifocal contact lenses.
  6. Be currently wearing lenses in an extended wear modality.
  7. Have a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses.
  8. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
  9. Be an employee (e.g., Investigator, Coordinator, Technician) or immediate family member of an employee (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse) of the clinical site.
  10. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities, or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis).
  11. Have a history of strabismus or amblyopia.
  12. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
  13. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).

Trial locations and contacts

4 sites in 1 country.

United States4 sites
  • New Bremen EyeCare

    New Bremen, Ohio, 45869

  • New River Vision Care

    Oak Hill, West Virginia, 25901

  • VisualEyes

    Roswell, Georgia, 30076

  • Botetourt Eyecare LLC

    Salem, Virginia, 24153

Other trials in United States

About this study

This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity.

Conditions
Visual Acuity
Being tested
B+L Infuse spherical soft contact lenses, J&J ACUVUE OASYS 1-Day spherical soft contact lenses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • B+L Infuse spherical soft contact lensesDevice

    Test lens

  • J&J ACUVUE OASYS 1-Day spherical soft contact lensesDevice

    Control lens

Study groups in NCT07174596
Study groupRoleWhat they receive
Test/Control/ControlExperimentalEligible 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.
Receives: Device: B+L Infuse spherical soft contact lenses; Device: J&J ACUVUE OASYS 1-Day spherical soft contact lenses
Control/Test/TestExperimentalEligible 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.
Receives: Device: B+L Infuse spherical soft contact lenses; Device: J&J ACUVUE OASYS 1-Day spherical soft contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visit

    Visual acuity (VA) will be collected for each eye at distance using Snellen charts at the fitting evaluation and after approximately 1-week of lens wear.

    Measured: At 1-week follow-up per wear period

  2. Proportion of Eyes with acceptable lens fit

    Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each eye.

    Measured: Up to 3-week follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2025
  2. Study start11 Sep 2025
  3. Primary completion27 Oct 2025
  4. Study completion27 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174596
Sponsor's protocol ID
CR-6617
Status last verified
Jul 2026
First submitted
11 Sep 2025
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A study testing B+L Infuse spherical soft contact lenses and J&J ACUVUE OASYS 1-Day spherical soft contact lenses in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Eyes Achieving 20/20 Distance Monocular Snellen VA or Better at the 1-week follow-up visit (time frame: At 1-week follow-up per wear period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in