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Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population

NCT04310566•Johnson & Johnson Vision Care, Inc.

Summary

This is a single-masked, crossover, randomized-controlled, dispensing clinical trial. A total of approximately 70 myopic eligible subjects will be targeted to complete the study.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all of the following criteria to be enrolled in the study.
•1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
•2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
•3. The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
•4. Subjects must own a wearable pair of spectacles if required for their distance vision.
•5. The subject must 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 1 month or more duration).
•6. The subject must 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 must be in the range of -1.25 D to -3.75 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.
+1 more criteria

Exclusion Criteria

•Potential subjects who meet any of the following criteria will be excluded from participating in the study:
•1. Currently pregnant or lactating.
•2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
•3. 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, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
•4. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
•5. A history of amblyopia, strabismus or binocular vision abnormality.
•6. Use of any of the following oral medications within 2 weeks prior to enrollment: oral retinoids, oral tetracyclines, anticholinergics, systemic/topical steroids. See section 9.1 for additional details regarding excluded systemic medications.
•7. Use of any ocular medication, with the exception of rewetting drops.
•8. History of herpetic keratitis.
•9. History of irregular cornea.
+8 more criteria

Locations (7)

Dr. James Weber & Associates, PA

Jacksonville, Florida, United States

VRC-East

Jacksonville, Florida, United States

Maitland Vision Center

Maitland, Florida, United States

Kannarr Eye Care

Pittsburg, Florida, United States

Visual Eyes

Roswell, Georgia, United States

ProCare Vision Centers

Granville, Ohio, United States

West Bay Eye Associates

Warwick, Rhode Island, United States

Key Dates

Start Date

February 21, 2020

Primary Completion Date

March 28, 2020

Completion Date

March 28, 2020

Last Updated

January 19, 2022

Enrollment

ACTUAL participants

Conditions

Visual Acuity

Interventions

JJVC Investigational Multifocal Contact Lens (senofilcon A c3)

DEVICE

Dailies Total 1® Multifocal Contact Lens

DEVICE

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Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 19, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of a Daily Disposable Novel Multifocal Contact Lens in a Myopic Population

Inclusion Criteria

Exclusion Criteria

Effect of Action Video Games and Stroboscopic Glasses on Dynamic Visual Acuity.

Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

Assessing the Turkish DDIVAT for Visual Acuity Measurement

Evaluation of a Digital Visual Acuity Device vs. Standard Visual Acuity Measurements

Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

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