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Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes

NCT04794751•Johnson & Johnson Vision Care, Inc.

View on ClinicalTrials.gov

Summary

This is a single-masked, 2×3 crossover, randomized, dispensing clinical trial to evaluate the visual performance and subjective responses of the JJVC Investigational Contact Lens.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Potential subjects must satisfy all 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" (Appendix E).
•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 medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See Table 9.1 for further examples.
•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)

VRC-East

Jacksonville, Florida, United States

St. Johns Eye Associates, PA

Saint Augustine, Florida, United States

Advanced Eyecare

Raytown, Missouri, United States

Spectrum Eyecare

Jamestown, New York, United States

Sacco Eye Group

Vestal, New York, United States

ProCare Vision Centers

Granville, Ohio, United States

Tyler Eye Associates

Tyler, Texas, United States

Key Dates

Start Date

March 13, 2021

Primary Completion Date

June 10, 2021

Completion Date

June 10, 2021

Last Updated

June 21, 2022

Enrollment

ACTUAL participants

Conditions

Visual Acuity

Interventions

JJVC Investigational Multifocal Contact Lens

DEVICE

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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: June 21, 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 Investigational Daily Disposable Multifocal Contact Lenses Produced With Different Manufacturing Processes

Inclusion Criteria

Exclusion Criteria

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

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