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Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes

NCT05222880•Johnson & Johnson Vision Care, Inc.

View on ClinicalTrials.gov

Summary

This is a single-masked, single-arm, dispensing clinical trial that will evaluate vision, eye health and fit acceptance.

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. 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 1 month 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 -1.25 D to -5.75 D or +0.75 D to +3.25 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. Be currently pregnant or lactating.
•2. Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
•3. 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, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens- Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
•4. 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.).
•5. Have a history of amblyopia, strabismus or binocular vision abnormality.
•6. Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.
•7. Use of any ocular medication, with the exception of rewetting drops.
•8. Have a history of herpetic keratitis.
•9. Have a history of irregular cornea.
+7 more criteria

Locations (12)

Vue Optical Boutique

Jacksonville, Florida, United States

Stam & Associates Eye Care

Jacksonville, Florida, United States

Maitland Vision Center - North Orlando Ave

Maitland, Florida, United States

Tallahassee Eye Center

Tallahassee, Florida, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Birmingham Vision Care

Bloomfield Hills, Michigan, United States

Eye Associates of New York

Manhattan, New York, United States

Sacco Eye Group

Vestal, New York, United States

Dr. David W. Ferris & Associates

Warwick, Rhode Island, United States

Optometry Group, LLC

Memphis, Tennessee, United States

Key Dates

Start Date

January 6, 2022

Primary Completion Date

February 28, 2022

Completion Date

February 28, 2022

Last Updated

April 13, 2023

Enrollment

140

ACTUAL participants

Conditions

Visual Acuity

Interventions

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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: April 13, 2023Data 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 Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes

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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