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.
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:
- 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, multifocal or monovision 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 (vertex corrected if ≥-4.25 D) must be in the range of -1.50 D to -5.50 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 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:
- 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 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).
- 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.
- Use of any ocular medication.
- Have a history of herpetic keratitis.
- Have a history of irregular cornea.
- Have a history of pathological dry eye.
- Have a history of glaucoma or glaucoma suspect.
- 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.
- Have participated in any contact lens or lens care product clinical trial within 15 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 sodium fluorescein.
- 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.
- Have any current ocular infection or inflammation.
- Have intraocular pressure in one or both eyes >21mmHg
- 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
- Recruiting
Paradigm Research Center, LLC
Houston, Texas, 77030
- Recruiting
Spectrum Eyecare
Jamestown, New York, 14701
- Completed
Pearson Research Center PA
Longwood, Florida, 32779
- Recruiting
Center for Ophthalmic and Vision Research/Eye Associates of New York
Manhattan, New York, 10022
- Completed
Total Eye Care
Memphis, Tennessee, 38119
- Active, not recruiting
VisualEyes
Roswell, Georgia, 30076
- Recruiting
Botetourt Eyecare, LLC
Salem, Virginia, 24153
- Active, not 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
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 group | Role | What they receive |
|---|---|---|
| Senofilcon A | Experimental | Eligible subjects will be randomized to the Senofilcon A Lens for the duration of the study. Receives: Device: Senofilcon A |
| Nelfilcon A | Active comparator | Eligible 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.
Mean binocular HLHC distance Visual Acuity
Mean binocular HLHC VA at distance (4m)
Measured: At 1-week follow-up
Mean binocular HLHC Intermediate Visual Acuity
Mean binocular HLHC VA at Intermediate (64cm)
Measured: At 1-week follow-up
Mean binocular HLHC Near Visual Acuity
Mean binocular HLHC VA at Near (40cm)
Measured: At 1-week follow-up
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)
Mean binocular HLHC distance Visual Acuity
Mean binocular HLHC VA at distance (4m)
Measured: At 1-month follow-up
Mean binocular HLHC Intermediate Visual Acuity
Mean binocular HLHC VA at Intermediate (64cm)
Measured: At 1-month follow-up
Mean binocular HLHC Near Visual Acuity
Mean binocular HLHC VA at Near (40cm)
Measured: At 1-month follow-up
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.
- First posted26 Aug 2026
- Study start10 Sep 2026
- Primary completion11 Dec 2026 (estimated)
- Study completion11 Dec 2026 (estimated)
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
- ClinicalTrials.gov ID
- NCT07788521
- Acronym / sponsor ID
- CR-6560
- Conditions
- Visual Acuity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Sep 2026 (actual)
- Primary completion
- 11 Dec 2026 (estimated)
- Study completion
- 11 Dec 2026 (estimated)
- First posted
- 26 Aug 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Senofilcon A | Experimental | Device: Senofilcon AEligible subjects will be randomized to the Senofilcon A Lens for the duration of the study. |
| Nelfilcon A | Active comparator | Device: Nelfilcon AEligible subjects will be randomized to the Nelfilcon A Lens for the duration of the study. |
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 |
|---|---|---|
| Senofilcon AACUVUE® Oasys MAX 1-Day Multifocal | Device | Senofilcon A |
| Nelfilcon ADAILIES® AquaComfort Plus® Multifocal | Device | Nelfilcon A |
Primary outcome
Mean binocular HLHC distance Visual Acuity
Time frame: At 1-week follow-up
Mean binocular HLHC VA at distance (4m)
Mean binocular HLHC Intermediate Visual Acuity
Time frame: At 1-week follow-up
Mean binocular HLHC VA at Intermediate (64cm)
Mean binocular HLHC Near Visual Acuity
Time frame: At 1-week follow-up
Mean binocular HLHC VA at Near (40cm)
Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.
Time frame: Up to 1-month follow-up
4 secondary outcomes
Mean binocular HLHC distance Visual Acuity
Time frame: At 1-month follow-up
Mean binocular HLHC Intermediate Visual Acuity
Time frame: At 1-month follow-up
Mean binocular HLHC Near Visual Acuity
Time frame: At 1-month follow-up
Incidence rate of Slit Lamp Findings (SLF)
Time frame: Up to 1-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
11 sites in 1 country: see every site and its status.
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.