Visual AcuityNCT07076160

Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses

A study testing INFUSE® One Day Multifocal and ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens in people with Visual Acuity and Presbyopia, run by Johnson & Johnson Vision Care, Inc. at 7 sites in United States.

Completed

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

Official record

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Trial summary

This is a 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate visual acuity. Read more about this study

Who is it for?: Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Visual Acuity, Presbyopia
What is being tested?: INFUSE® One Day Multifocal and ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 7 sitesUnited States
Study dates: 24 Jul 2025to 20 Sep 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

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 at least 40 years of age and not greater than 70 years of age at the time of consent.
Own a wearable pair of spectacles if required for their distance vision.
Be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 2 days per week for at least 6 hours per wear day, for 30 days or more duration).
Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, monovision or multifocal contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
The subject's distance spherical equivalent refraction must be in the range of +1.00 to +4.00 or -1.00 D to -4.00 D in each eye.
The subject's refractive cylinder must be ≤0.75 D in each eye.
The subject's ADD power must be in the range of +0.75 D to +2.50 D.
The subject must have distance best corrected visual acuity of 20/20-3 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.
Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
Have been diagnosed with diabetes.
Have any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This includes, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
Have any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
Have a history of amblyopia, strabismus or binocular vision abnormality.
Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.
Be currently using any ocular medications with the exception of rewetting drops.
Have a history of herpetic keratitis.
Have a history of irregular cornea.
Have a history of pathological dry eye.
Have participated in any contact lens or lens care product clinical trial within 7 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, sibling of the employee or their spouse) of the clinical site.
Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
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 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 any current ocular infection or inflammation.

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Dr. James Weber & Associates, PA - City Square Blvd
Jacksonville, Florida, 32218
VRC
Jacksonville, Florida, 32256
Pearson Research Center, PA
Longwood, Florida, 32779
Maitland Vision Center - North Orlando Ave
Maitland, Florida, 32751
Luxe Vision and Optical
Powell, Ohio, 43065
Sacco Eye Group
Vestal, New York, 13850
Dr. David W. Ferris & Associates
Warwick, Rhode Island, 02888

Other trials in United States

About this study

This is a 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial to evaluate visual acuity.

Conditions: Visual Acuity, Presbyopia
Being tested: INFUSE® One Day Multifocal, ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Medical subject headings: Presbyopia

What participants receive

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

INFUSE® One Day MultifocalDevice
Test Lens
ACUVUE® OASYS MAX 1-Day Multifocal Contact LensDevice
Control Lens

Study groups in NCT07076160
Study group	Role	What they receive
Test/Control/Control	Experimental	Eligible subjects will be randomized into the Test/Control/Control sequence. Receives: Device: INFUSE® One Day Multifocal; Device: ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens
Control/Test/Test	Experimental	Eligible subjects will be randomized into the Control/Test/Test sequence. Receives: Device: INFUSE® One Day Multifocal; Device: ACUVUE® OASYS MAX 1-Day Multifocal Contact Lens

What is being measured

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

High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Distance (4m)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: 1-Week Follow-up
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Intermediate (64cm)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: 1-Week Follow-up
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Near (40cm)
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Measured: 1-Week Follow-up

Timeline

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

24 Jul 202520 Sep 2025

First posted22 Jul 2025
Study start24 Jul 2025
Primary completion20 Sep 2025
Study completion20 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07076160
Sponsor's protocol ID: CR-6612
Status last verified: Oct 2026
First submitted: 14 Jul 2025
Last updated: 15 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
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Active, not recruitingPhase 2
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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses
ClinicalTrials.gov ID: NCT07076160
Acronym / sponsor ID: CR-6612
Conditions: Visual Acuity, Presbyopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 24 Jul 2025 (actual)
Primary completion: 20 Sep 2025 (actual)
Study completion: 20 Sep 2025 (actual)
First posted: 22 Jul 2025 (actual)
Results: Posted 15 Oct 2026

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 6-visit, single-masked, multi-site, 2×3 crossover, randomized-controlled, dispensing clinical trial 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: INFUSE® One Day Multifocal, Device: ACUVUE® OASYS MAX 1-Day Multifocal Contact LensEligible subjects will be randomized into the Test/Control/Control sequence.
Control/Test/Test	Experimental	Device: INFUSE® One Day Multifocal, Device: ACUVUE® OASYS MAX 1-Day Multifocal Contact LensEligible subjects will be randomized into the Control/Test/Test sequence.

Who may qualify

Ages: 40 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older 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
INFUSE® One Day MultifocalTest Lens	Device	Control/Test/Test, Test/Control/Control
ACUVUE® OASYS MAX 1-Day Multifocal Contact LensControl Lens	Device	Control/Test/Test, Test/Control/Control

Primary outcome

High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Distance (4m)
Time frame: 1-Week Follow-up
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Intermediate (64cm)
Time frame: 1-Week Follow-up
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Near (40cm)
Time frame: 1-Week Follow-up
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.

Results and safety

Results posted to the registry on 15 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Kalifilcon A/ Senofilcon A C3/ Senofilcon A C3	36	36
Senofilcon A C3/ Kalifilcon A/ Kalifilcon A	34	34

Primary outcome: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Distance (4m)

Time frame: 1-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Kalifilcon A n = 67	Senofilcon A C3 n = 67
Value	-0.058 (0.1013)	-0.071 (0.1002)

Kalifilcon A vs Senofilcon A C3: Least Square Means Difference: 0.014 (95% CI -0.002 to 0.030), Mixed Models Analysis

Population analysed: All subjects who completed the study without substantial deviation from protocol, with data collected at the 1-week follow-up.

Primary outcome: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Intermediate (64cm)

Time frame: 1-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Kalifilcon A n = 67	Senofilcon A C3 n = 67
Value	-0.045 (0.0968)	-0.049 (0.0912)

Kalifilcon A vs Senofilcon A C3: Least Square Means Difference: 0.004 (95% CI -0.012 to 0.021), Mixed Models Analysis

Population analysed: All subjects who completed the study without substantial deviation from protocol, with data collected at the 1-week follow-up.

Primary outcome: High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Near (40cm)

Time frame: 1-Week Follow-up. Mean (Standard Deviation). Unit: logMAR

Measure	Kalifilcon A n = 67	Senofilcon A C3 n = 67
Value	0.076 (0.0999)	0.069 (0.0980)

Kalifilcon A vs Senofilcon A C3: Least Square Means Difference: 0.007 (95% CI -0.012 to 0.026), Mixed Models Analysis

Population analysed: All subjects who completed the study without substantial deviation from protocol, with data collected at the 1-week follow-up.

Adverse events

Time frame: Throughout the duration of the study, adverse events were monitored for approximately 32 days per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Kalifilcon A	0 of 70 (0%)	0 of 70 (0%)	0 of 70
Senofilcon A C3	0 of 70 (0%)	0 of 70 (0%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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?

Yes. Results are posted in the registry (first posted 15 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

High Luminance High Contrast (HLHC) Binocular logMAR Visual Acuity at Distance (4m) (time frame: 1-Week Follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07076160.

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 15 Oct 2026.