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Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population | Clinical Trials | Clareo Health

COMPLETEDNA

Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic Population

NCT04534517•Johnson & Johnson Vision Care, Inc.

View on ClinicalTrials.gov

Summary

The clinical study is a bilateral, single-masked (partial), single-arm, clinical trial. A total of approximately 60 eligible subjects both near-sighted and far-sighted, will be targeted to complete the study. Subjects will be fit in the study lens for approximately 2-4 days then undergo lens optimization, if required. Subjects will then be given a new pair of lenses that will be worn for approximately 2 weeks.

Eligibility

Age

40 - 70 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•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. wears lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month of 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 (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.
•10. The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

Exclusion Criteria

•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, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
•5. A history of amblyopia, strabismus or binocular vision abnormality.
•6. History of glaucoma, macular degeneration, recurrent corneal erosions, recurrent styes, herpetic keratitis, irregular cornea or pathological dry eye.
•7. Use of any of the following medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, corticosteroids.
•8. Use of any ocular medication, with the exception of rewetting drops.
•9. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
•10. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
+4 more criteria

Locations (11)

Dr. James Weber & Associates, PA

Jacksonville, Florida, United States

Sabal Eye Care

Longwood, Florida, United States

Maitland Vision Center

Maitland, Florida, United States

VisualEyes

Roswell, Georgia, United States

VisionPoint Eye Center

Bloomington, Illinois, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Advanced Eyecare

Raytown, Missouri, United States

Sacco Eye Group

Vestal, New York, United States

ProCare Vision Centers

Granville, Ohio, United States

Dr. David W. Ferris & Associates

Warwick, Rhode Island, United States

Key Dates

Start Date

August 7, 2020

Primary Completion Date

September 29, 2020

Completion Date

September 29, 2020

Last Updated

January 13, 2022

Enrollment

119

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: January 13, 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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Clinical Evaluation of a Daily Wear Reusable Multifocal Optical Design in a Presbyopic 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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