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.
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.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- 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.
- 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.
- Possess a wearable pair of spectacles that provide correction for distance vision.
- The spherical equivalent of the subject's vertex-corrected distance refraction must be between -1.00 D and -6.00 D in each eye.
- 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:
- Be currently pregnant or lactating.
- Be currently using any ocular medications or have any ocular infection of any type.
- 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.
- Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
- Be currently wearing monovision or multifocal contact lenses.
- Be currently wearing lenses in an extended wear modality.
- Have a known hypersensitivity or allergic reaction to silicone hydrogel soft contact lenses.
- Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- 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.
- 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).
- Have a history of strabismus or amblyopia.
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
- 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
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 group | Role | What they receive |
|---|---|---|
| Test/Control/Control | Experimental | 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. Receives: Device: B+L Infuse spherical soft contact lenses; Device: J&J ACUVUE OASYS 1-Day spherical soft contact lenses |
| Control/Test/Test | Experimental | 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. 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.
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
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.
- First posted16 Sep 2025
- Study start11 Sep 2025
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual AcuityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Approved Contact Lenses
- ClinicalTrials.gov ID
- NCT07174596
- Acronym / sponsor ID
- CR-6617
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, randomized, controlled, subject-masked, bilateral, dispensing, multi-site, 2 lenses × 3 wearing periods crossover study to evaluate visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test/Control/Control | Experimental | Device: B+L Infuse spherical soft contact lenses, Device: J&J ACUVUE OASYS 1-Day spherical soft contact lensesEligible 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. |
| Control/Test/Test | Experimental | Device: B+L Infuse spherical soft contact lenses, Device: J&J ACUVUE OASYS 1-Day spherical soft contact lensesEligible 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 may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| B+L Infuse spherical soft contact lensesTest lens | Device | Control/Test/Test, Test/Control/Control |
| J&J ACUVUE OASYS 1-Day spherical soft contact lensesControl lens | Device | Control/Test/Test, Test/Control/Control |
Primary outcome
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
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.
Proportion of Eyes with acceptable lens fit
Time frame: Up to 3-week follow-up
Acceptable lens fit will be assessed at all study visits (scheduled and unscheduled) for each eye.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
4 sites in 1 country: see every site and its status.
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.