NCT07788521 · Johnson & Johnson Vision Care, Inc.
Comparison of ACUVUE® OASYS MAX 1-Day Multifocal and DAILIES® AquaComfort Plus® Multifocal
What this study is about
This study is a 4-visit, multi-site, forward-looking, controlled, randomly assigned, single-masked (subjects), two-treatment group$1 parallel group, bilateral, dispensing clinical trial to compare the performance of the Test lens to the Control lens in terms of safety and effectiveness.
View original scientific description
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.
Interventions
DEVICE
Senofilcon A
ACUVUE® Oasys MAX 1-Day Multifocal
DEVICE
Nelfilcon A
DAILIES® AquaComfort Plus® Multifocal
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Where
- Longwood, Florida
- Roswell, Georgia
- St Louis, Missouri
- Jamestown, New York
- Manhattan, New York
- Vestal, New York
- Warwick, Rhode Island
- Memphis, Tennessee
- Houston, Texas
- Tyler, Texas
- Salem, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2026 · Source of record for eligibility and locations