ClinicalTrials.gg
RecruitingNCT07788521Updated Nov 6, 2026

Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal

An interventional study of Senofilcon A and Nelfilcon A in Visual Acuity, sponsored by Johnson & Johnson Vision Care, Inc.. Recruiting at 11 sites in United States. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Johnson & Johnson Vision Care, Inc. (part of Johnson & Johnson) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Updated Nov 6, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
40 Years to 70 Years
Sex
All
01

Study summary

This study is a 4-visit, multi-site, prospective, controlled, randomized, single-masked (subjects), two-arm parallel group, bilateral, dispensing clinical trial to compare the performance of the Test lens to the Control lens in terms of safety and efficacy.

02

Conditions studied

  • Visual Acuity
03

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 221 studies on the registry; 1 is open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 103 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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

  1. Read, understand, and sign the STATEMENT OF and receive a fully executed copy of the form.
  2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  3. Be at least 40 years of age and not greater than 70 years of age at the time of consent.
  4. Own a wearable pair of spectacles if required for their distance vision.
  5. 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).
  6. Either already be wearing a presbyopic contact lens correction (e.g., reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
  7. The subject's distance spherical equivalent refraction (vertex corrected if ≥-4.25 D) must be in the range of -1.50 D to -5.50 D in each eye.
  8. The subject's refractive cylinder must be ≤0.75 D in each eye.
  9. The subject's ADD power must be in the range of +0.75 D to +2.50 D.
  10. The subject must have distance best corrected visual acuity of 0.0 logMAR (20/20 Snellen, 5.0 on the China standard 5-point logMAR visual acuity scale) 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. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  3. Have been diagnosed with diabetes.
  4. Have any active or ongoing systemic disease, disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
  5. 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.).
  6. Have a history of amblyopia, strabismus or binocular vision abnormality.
  7. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled .
  8. Use of any ocular medication.
  9. Have a history of herpetic keratitis.
  10. Have a history of irregular cornea.
  11. Have a history of pathological dry eye.
  12. Have a history of glaucoma or glaucoma suspect.
  13. Have a history of any retinal disease/condition that may interfere with any of the study assessments or are not stable and have potential to progress during the study.
  14. Have participated in any contact lens or lens care product clinical trial within 15 days prior to study enrollment.
  15. 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.
  16. Have any known or allergic reaction to sodium fluorescein.
  17. Have Grade 3 or greater palpebral conjunctival observations or Grade 2 or greater slit lamp findings (e.g. corneal edema, corneal vascularization, corneal staining, bulbar injection, etc.) on the ISO 11980 classification scale, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  18. Have any current ocular infection or inflammation.
  19. Have intraocular pressure in one or both eyes >21mmHg
  20. Have signs of any retinal disease/conditions that may interfere with any of the study assessments or are not stable and have potential to progress during the study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
150 participants (estimated)

Study arms

  • Experimental
    Senofilcon A

    Eligible subjects will be randomized to the Senofilcon A Lens for the duration of the study.

    Device: Senofilcon A

  • Active comparator
    Nelfilcon A

    Eligible subjects will be randomized to the Nelfilcon A Lens for the duration of the study.

    Device: Nelfilcon A

Interventions

  • DeviceSenofilcon A

    ACUVUE® Oasys MAX 1-Day Multifocal

  • DeviceNelfilcon A

    DAILIES® AquaComfort Plus® Multifocal

06

What researchers measure

Primary outcomes

  1. Mean binocular HLHC distance Visual Acuity

    Mean binocular HLHC VA at distance (4m)

    Time frame: At 1-week follow-up

  2. Mean binocular HLHC Intermediate Visual Acuity

    Mean binocular HLHC VA at Intermediate (64cm)

    Time frame: At 1-week follow-up

  3. Mean binocular HLHC Near Visual Acuity

    Mean binocular HLHC VA at Near (40cm)

    Time frame: At 1-week follow-up

  4. Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.

    Time frame: Up to 1-month follow-up

Secondary outcomes

  1. Mean binocular HLHC distance Visual Acuity

    Mean binocular HLHC VA at distance (4m)

    Time frame: At 1-month follow-up

  2. Mean binocular HLHC Intermediate Visual Acuity

    Mean binocular HLHC VA at Intermediate (64cm)

    Time frame: At 1-month follow-up

  3. Mean binocular HLHC Near Visual Acuity

    Mean binocular HLHC VA at Near (40cm)

    Time frame: At 1-month follow-up

  4. Incidence rate of Slit Lamp Findings (SLF)

    Slit lamp findings will be assessed for each eye at all study visits (scheduled and unscheduled) by grade. SLFs will be evaluated and graded using the ISO 11980 Grading scale from 0 to 4, where Grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e., Grade 1 = trace, Grade 2 = mild, Grade 3 = moderate and Grade 4 = severe).

    Time frame: Up to 1-month follow-up

07

Study locations

4 of 11 sites recruiting
  • Pearson Research Center PA
    Longwood, Florida 32779, United States
    Completed

    Not enrolling at this site.

  • VisualEyes
    Roswell, Georgia 30076, United States
    Active, not recruiting

    Not enrolling at this site.

  • The Koetting Associates
    St Louis, Missouri 63144, United States
    Active, not recruiting

    Not enrolling at this site.

  • Spectrum Eyecare
    Jamestown, New York 14701, United States
    Recruiting
  • Center for Ophthalmic and Vision Research/Eye Associates of New York
    Manhattan, New York 10022, United States
    Recruiting
  • Sacco Eye Group
    Vestal, New York 13850, United States
    Active, not recruiting

    Not enrolling at this site.

  • Dr. David W. Ferris & Associates
    Warwick, Rhode Island 02888, United States
    Active, not recruiting

    Not enrolling at this site.

  • Total Eye Care
    Memphis, Tennessee 38119, United States
    Completed

    Not enrolling at this site.

  • Paradigm Research Center, LLC
    Houston, Texas 77030, United States
    Recruiting
  • Tyler Eye Associates
    Tyler, Texas 75703, United States
    Active, not recruiting

    Not enrolling at this site.

  • Botetourt Eyecare, LLC
    Salem, Virginia 24153, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: 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

Data sharing details ↗ · yoda.yale.edu

No publications or documents are linked to this record.

09

Timeline

3 registry updates since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it moved

Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 3 months after the start.

Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Sep 2026, on Sep 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Aug 23, 2026
First posted
Aug 26, 2026
StartActual
Sep 10, 2026was Aug 2026
Primary completionEst.
Dec 11, 2026
CompletionEst.
Dec 11, 2026
Last update
Nov 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 29, 2026
Sites
11 sites changed recruiting status (5 now active, not recruiting, 4 now recruiting, …)
Show 11 sites
  • Pearson Research Center PA · Longwood, United Statesno status→Completed
  • VisualEyes · Roswell, United Statesno status→Active, not recruiting
  • The Koetting Associates · St Louis, United Statesno status→Active, not recruiting
  • Spectrum Eyecare · Jamestown, United Statesno status→Recruiting
  • Center for Ophthalmic and Vision Research/Eye Associates of New York · Manhattan, United Statesno status→Recruiting
  • Sacco Eye Group · Vestal, United Statesno status→Active, not recruiting
  • Dr. David W. Ferris & Associates · Warwick, United Statesno status→Active, not recruiting
  • Total Eye Care · Memphis, United Statesno status→Completed
  • Paradigm Research Center, LLC · Houston, United Statesno status→Recruiting
  • Tyler Eye Associates · Tyler, United Statesno status→Active, not recruiting
  • Botetourt Eyecare, LLC · Salem, United Statesno status→Recruiting
across 3 updates, Sep 29, 2026 – Nov 6, 2026
Start date
Aug 28, 2026→Sep 10, 2026 (actual)
Sep 29, 2026
Show all 3 updates
  1. Nov 6, 2026
    5 sites changed recruiting status (3 now active, not recruiting, 2 now completed)
    Show 5 sites
    • Pearson Research Center PA · Longwood, United StatesActive, not recruiting→Completed
    • The Koetting Associates · St Louis, United StatesRecruiting→Active, not recruiting
    • Sacco Eye Group · Vestal, United StatesRecruiting→Active, not recruiting
    • Dr. David W. Ferris & Associates · Warwick, United StatesRecruiting→Active, not recruiting
    • Total Eye Care · Memphis, United StatesActive, not recruiting→Completed
  2. Nov 3, 2026
    3 sites changed recruiting status (3 now active, not recruiting)
    Show 3 sites
    • VisualEyes · Roswell, United StatesRecruiting→Active, not recruiting
    • Total Eye Care · Memphis, United StatesRecruiting→Active, not recruiting
    • Tyler Eye Associates · Tyler, United StatesRecruiting→Active, not recruiting
    + 1 other change: verification date
  3. Sep 29, 2026
    Not yet recruiting→Recruiting
    11 sites changed recruiting status (10 now recruiting, 1 now active, not recruiting)
    Show 11 sites
    • Pearson Research Center PA · Longwood, United Statesno status→Active, not recruiting
    • VisualEyes · Roswell, United Statesno status→Recruiting
    • The Koetting Associates · St Louis, United Statesno status→Recruiting
    • Spectrum Eyecare · Jamestown, United Statesno status→Recruiting
    • Center for Ophthalmic and Vision Research/Eye Associates of New York · Manhattan, United Statesno status→Recruiting
    • Sacco Eye Group · Vestal, United Statesno status→Recruiting
    • Dr. David W. Ferris & Associates · Warwick, United Statesno status→Recruiting
    • Total Eye Care · Memphis, United Statesno status→Recruiting
    • Paradigm Research Center, LLC · Houston, United Statesno status→Recruiting
    • Tyler Eye Associates · Tyler, United Statesno status→Recruiting
    • Botetourt Eyecare, LLC · Salem, United Statesno status→Recruiting
    Start date Aug 28, 2026→Sep 10, 2026 (now actual)
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07788521
Responsible party
Sponsor
First posted
Aug 26, 2026
Start date
Sep 10, 2026
Primary completion
Dec 11, 2026 (estimated)
Completion
Dec 11, 2026 (estimated)
Last update
Nov 6, 2026

Study contacts

Study Contact
Contact
tkarkkai@its.jnj.com
1-800-843-2020
Johnson & Johnson Vision Care, Inc. Clinical Trial
study director · Johnson & Johnson Vision Care, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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