Recruiting

Test Lens vs. Control Lens

Sponsor:

Johnson & Johnson Vision Care, Inc.

Code:

NCT07788521

Conditions

Visual Acuity

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

Interventions

Senofilcon A

Nelfilcon A

Study Details

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

Study ID

NCT07788521

Start date

Sep 10, 2026

Status verified date

Sep, 2026

Completion date

Dec 11, 2026

Anticipated

Primary completion date

Dec 11, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Senofilcon A

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

active comparator: Nelfilcon A

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

Interventions

Senofilcon A

ACUVUE® Oasys MAX 1-Day Multifocal

Nelfilcon A

DAILIES® AquaComfort Plus® Multifocal

Primary outcome measure

  • Mean binocular HLHC distance Visual Acuity [ Time Frame: At 1-week follow-up ]
  • Mean binocular HLHC Intermediate Visual Acuity [ Time Frame: At 1-week follow-up ]
  • Mean binocular HLHC Near Visual Acuity [ Time Frame: At 1-week follow-up ]
  • Incidence rate of study-lens related (i.e. related and possibly related) ocular adverse events. [ Time Frame: Up to 1-month follow-up ]

Central Contacts and Locations

Central contacts

Locations

VisualEyes

Recruiting

Roswell, Georgia, United States, 30076

The Koetting Associates

Recruiting

St Louis, Missouri, United States, 63144

Spectrum Eyecare

Recruiting

Jamestown, New York, United States, 14701

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

Recruiting

Manhattan, New York, United States, 10022

Sacco Eye Group

Recruiting

Vestal, New York, United States, 13850

Dr. David W. Ferris & Associates

Recruiting

Warwick, Rhode Island, United States, 02888

Total Eye Care

Recruiting

Memphis, Tennessee, United States, 38119

Paradigm Research Center, LLC

Recruiting

Houston, Texas, United States, 77030

Tyler Eye Associates

Recruiting

Tyler, Texas, United States, 75703

Botetourt Eyecare, LLC

Recruiting

Salem, Virginia, United States, 24153

More Information

Sponsor

Johnson & Johnson Vision Care, Inc.

Last update posted

Sep 29, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-30. This information was provided to ClinicalTrials.gov by Johnson & Johnson Vision Care, Inc. on 2026-09-29. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.