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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07788521
Enrollment
150
Registered
2026-08-26
Start date
2026-08-28
Completion date
2026-12-11
Last updated
2026-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Visual Acuity

Brief 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.

Interventions

DEVICESenofilcon A

ACUVUE® Oasys MAX 1-Day Multifocal

DAILIES® AquaComfort Plus® Multifocal

Sponsors

Johnson & Johnson Vision Care, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
Mean binocular HLHC distance Visual AcuityAt 1-week follow-upMean binocular HLHC VA at distance (4m)
Mean binocular HLHC Intermediate Visual AcuityAt 1-week follow-upMean binocular HLHC VA at Intermediate (64cm)
Mean binocular HLHC Near Visual AcuityAt 1-week follow-upMean binocular HLHC VA at Near (40cm)
Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events.Up to 1-month follow-up

Secondary

MeasureTime frameDescription
Mean binocular HLHC distance Visual AcuityAt 1-month follow-upMean binocular HLHC VA at distance (4m)
Mean binocular HLHC Intermediate Visual AcuityAt 1-month follow-upMean binocular HLHC VA at Intermediate (64cm)
Mean binocular HLHC Near Visual AcuityAt 1-month follow-upMean binocular HLHC VA at Near (40cm)
Incidence rate of Slit Lamp Findings (SLF)Up to 1-month follow-upSlit 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).

Countries

United States

Contacts

CONTACTStudy Contact
tkarkkai@its.jnj.com1-800-843-2020
STUDY_DIRECTORJohnson & Johnson Vision Care, Inc. Clinical Trial

Johnson & Johnson Vision Care, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026