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Not yet recruiting

NCT Number: NCT07788521

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

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.

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Key information

Conditions

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pearson Research Center PA, Longwood, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Senofilcon A

Device

ACUVUE® Oasys MAX 1-Day Multifocal

Nelfilcon A

Device

DAILIES® AquaComfort Plus® Multifocal

Primary outcomes

  1. Mean binocular HLHC distance Visual Acuity

    Time frame: At 1-week follow-up

    Mean binocular HLHC VA at distance (4m)

  2. Mean binocular HLHC Intermediate Visual Acuity

    Time frame: At 1-week follow-up

    Mean binocular HLHC VA at Intermediate (64cm)

  3. Mean binocular HLHC Near Visual Acuity

    Time frame: At 1-week follow-up

    Mean binocular HLHC VA at Near (40cm)

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

    Time frame: Up to 1-month follow-up

Secondary outcomes

  1. Mean binocular HLHC distance Visual Acuity

    Time frame: At 1-month follow-up

    Mean binocular HLHC VA at distance (4m)

  2. Mean binocular HLHC Intermediate Visual Acuity

    Time frame: At 1-month follow-up

    Mean binocular HLHC VA at Intermediate (64cm)

  3. Mean binocular HLHC Near Visual Acuity

    Time frame: At 1-month follow-up

    Mean binocular HLHC VA at Near (40cm)

  4. Incidence rate of Slit Lamp Findings (SLF)

    Time frame: Up to 1-month follow-up

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Study Contact

CONTACT

[email protected]

1-800-843-2020

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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