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

NCT07788521 | Not Yet Recruiting FDA Device

• 1 other identifier: CR-6560
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 11

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.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (4)

• Mean binocular HLHC distance Visual Acuity

  Mean binocular HLHC VA at distance (4m)

  At 1-week follow-up

• Mean binocular HLHC Intermediate Visual Acuity

  Mean binocular HLHC VA at Intermediate (64cm)

  At 1-week follow-up

• Mean binocular HLHC Near Visual Acuity

  Mean binocular HLHC VA at Near (40cm)

  At 1-week follow-up

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

  Up to 1-month follow-up

Secondary Outcomes (4)

• Mean binocular HLHC distance Visual Acuity

  At 1-month follow-up

• Mean binocular HLHC Intermediate Visual Acuity

  At 1-month follow-up

• Mean binocular HLHC Near Visual Acuity

  At 1-month follow-up

• Incidence rate of Slit Lamp Findings (SLF)

  Up to 1-month follow-up

Study Arms (2)

Senofilcon A

EXPERIMENTAL

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

Device: Senofilcon A

Nelfilcon A

ACTIVE COMPARATOR

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

Device: Nelfilcon A

Interventions

Senofilcon A DEVICE

ACUVUE® Oasys MAX 1-Day Multifocal

Senofilcon A

Nelfilcon A DEVICE

DAILIES® AquaComfort Plus® Multifocal

Nelfilcon A

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (11)

Pearson Research Center PA

Longwood, Florida, 32779, United States

Location

VisualEyes

Roswell, Georgia, 30076, United States

Location

The Koetting Associates

St Louis, Missouri, 63144, United States

Location

Spectrum Eyecare

Jamestown, New York, 14701, United States

Location

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

Manhattan, New York, 10022, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Dr. David W. Ferris & Associates

Warwick, Rhode Island, 02888, United States

Location

Total Eye Care

Memphis, Tennessee, 38119, United States

Location

Paradigm Research Center, LLC

Houston, Texas, 77030, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

Botetourt Eyecare, LLC

Salem, Virginia, 24153, United States

Location

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Central Study Contacts

Study Contact

CONTACT

1-800-843-2020; tkarkkai@its.jnj.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2026
• First Posted: August 26, 2026
• Study Start: August 28, 2026
• Primary Completion (Estimated): December 11, 2026
• Study Completion (Estimated): December 11, 2026
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

US (11)