AzTrials
AzTrials

Visual AcuityNCT07788521

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

A study testing Senofilcon A and Nelfilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 11 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. 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
What is being tested?
Senofilcon A and Nelfilcon A
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
11 sitesUnited States
Study dates
10 Sep 2026to 11 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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:

  1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT 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, autoimmune 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 immunosuppressive 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 corticosteroids.
  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 hypersensitivity 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.

Trial locations and contacts

11 sites in 1 country. Contact the study team or a site near you to ask about taking part.

11 sites in 1 country

United States11 sites, 4 recruiting
  • Paradigm Research Center, LLC

    Houston, Texas, 77030

    Recruiting
  • Spectrum Eyecare

    Jamestown, New York, 14701

    Recruiting
  • Pearson Research Center PA

    Longwood, Florida, 32779

    Completed
  • Center for Ophthalmic and Vision Research/Eye Associates of New York

    Manhattan, New York, 10022

    Recruiting
  • Total Eye Care

    Memphis, Tennessee, 38119

    Completed
  • VisualEyes

    Roswell, Georgia, 30076

    Active, not recruiting
  • Botetourt Eyecare, LLC

    Salem, Virginia, 24153

    Recruiting
  • The Koetting Associates

    St Louis, Missouri, 63144

    Active, not recruiting
  • Tyler Eye Associates

    Tyler, Texas, 75703

    Active, not recruiting
  • Sacco Eye Group

    Vestal, New York, 13850

    Active, not recruiting
  • Dr. David W. Ferris & Associates

    Warwick, Rhode Island, 02888

    Active, not recruiting

Other trials in United States

About this study

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.

Conditions
Visual Acuity
Being tested
Senofilcon A, Nelfilcon A

What participants receive

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

  • Senofilcon ADevice

    ACUVUE® Oasys MAX 1-Day Multifocal

  • Nelfilcon ADevice

    DAILIES® AquaComfort Plus® Multifocal

Study groups in NCT07788521
Study groupRoleWhat they receive
Senofilcon AExperimentalEligible subjects will be randomized to the Senofilcon A Lens for the duration of the study.
Receives: Device: Senofilcon A
Nelfilcon AActive comparatorEligible subjects will be randomized to the Nelfilcon A Lens for the duration of the study.
Receives: Device: Nelfilcon A

What is being measured

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

  1. Mean binocular HLHC distance Visual Acuity

    Mean binocular HLHC VA at distance (4m)

    Measured: At 1-week follow-up

  2. Mean binocular HLHC Intermediate Visual Acuity

    Mean binocular HLHC VA at Intermediate (64cm)

    Measured: At 1-week follow-up

  3. Mean binocular HLHC Near Visual Acuity

    Mean binocular HLHC VA at Near (40cm)

    Measured: At 1-week follow-up

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

    Measured: Up to 1-month follow-up

Secondary outcomes (4)
  1. Mean binocular HLHC distance Visual Acuity

    Mean binocular HLHC VA at distance (4m)

    Measured: At 1-month follow-up

  2. Mean binocular HLHC Intermediate Visual Acuity

    Mean binocular HLHC VA at Intermediate (64cm)

    Measured: At 1-month follow-up

  3. Mean binocular HLHC Near Visual Acuity

    Mean binocular HLHC VA at Near (40cm)

    Measured: 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).

    Measured: Up to 1-month 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 posted26 Aug 2026
  2. Study start10 Sep 2026
  3. Primary completion11 Dec 2026 (estimated)
  4. Study completion11 Dec 2026 (estimated)

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07788521
Sponsor's protocol ID
CR-6560
Status last verified
Nov 2026
First submitted
23 Aug 2026
Last updated
6 Nov 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 Senofilcon A and Nelfilcon A in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 11 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Study Contact (1-800-843-2020, tkarkkai@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean binocular HLHC distance Visual Acuity (time frame: At 1-week follow-up). The study lists 4 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 Nov 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