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Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses | Clinical Trials | Clareo Health

COMPLETEDNA

Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

NCT04974697•Johnson & Johnson Vision Care, Inc.

Summary

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. There will be one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical performance of investigational multifocal toric contact lenses.

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 and not more than 70 years of age at the time of screening.
•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 for at least 8 hours per day at least two days per week for the past 4 weeks).
•6. Be already 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 component of their refraction must be in the range of either -1.25 D to -3.75 D, or +1.25 D to +3.75 D.
•8. The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye, with the cylinder axes in the range of 90°±30°.
•9. The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
+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. By self-report, have any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study.
•3. Use systemic medications that may interfere with contact lens wear or cause blurred vision.
•4. Currently use ocular medication (with the exception of rewetting drops).
•5. Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
•6. Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.).
•7. Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report.
•8. Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
•9. Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
+4 more criteria

Locations (8)

Stam & Associates Eye Care

Jacksonville, Florida, United States

VRC-West

Jacksonville, Florida, United States

Maitland Vision Center

Maitland, Florida, United States

Kannarr Eye Care

Pittsburg, Kansas, United States

Birmingham Vision Care

Bloomfield Township, Michigan, United States

Eye Associates of New York

New York, New York, United States

Sacco Eye Group

Vestal, New York, United States

Tyler Eye Associates

Tyler, Texas, United States

Key Dates

Start Date

July 19, 2021

Primary Completion Date

October 29, 2021

Completion Date

October 29, 2021

Last Updated

November 14, 2022

Enrollment

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: November 14, 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 Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

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

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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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