Evaluation of a Reusable Silicone Hydrogel Multifocal Contact Lens

NCT04189224 | Completed Results FDA Device

• 1 other identifier: CR-6372
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief Summary

This study is a randomized, single-masked, crossover clinical trial. There are two study lenses. Each lens will be dispensed for 3 ± 1 days and then an optimization visit will occur. The final lens pair will be dispensed for 12 ± 2 days and the follow-up on the final lens pair will occur. The second study lenses will then be fit and the above sequence repeated.

Conditions

Presbyopia

Outcome Measures

Primary Outcomes (3)

• Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Bright

  The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.

  2-Week Follow-up

• Binocular Contact Lens-Corrected Visual Performance Under Standard High Contrast Dim With Goggles

  The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.

  2-Week Follow-up

• Binocular Contact Lens-Corrected Visual Performance Under Standard Low Contrast Bright

  The contact lens-corrected visual performance on logMAR scale was evaluated binocularly under high luminance high contrast, dim luminance high contrast and high luminance low contrast conditions at 4 meters (distance), 64 cm (intermediate) and 40 cm (near) using ETDRS/reduced Guillon-Poling charts. A value of 0.0 logMAR equates to 20/20 vision on a Snellen Scale. Lower values indicate better visual performance. The average visual performance was reported for each lens type and distance.

  2-Week Follow-up

Secondary Outcomes (4)

• Overall Vision Scores

  2-Week Follow-up

• Overall Comfort Scores

  2-Week Follow-up

• Number of Grade 3 or Higher Slit Lamp Findings

  2-Week Follow-up

• Proportion of Subjects That Reported Ocular Symptoms

  2-Week Follow-up

Study Arms (2)

Test/Control

EXPERIMENTAL

Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Test/Control.

Device: JJV Investigational Multifocal Contact Lens; Device: 1-Day Acuvue® Moist Brand Multifocal Contact Lens

Control/Test

EXPERIMENTAL

Hyperopic subjects that are habitual soft contact lens wearers and have presbyopia will be randomized to sequence, Control/Test.

Device: JJV Investigational Multifocal Contact Lens; Device: 1-Day Acuvue® Moist Brand Multifocal Contact Lens

Interventions

JJV Investigational Multifocal Contact Lens DEVICE

TEST

Control/Test; Test/Control

1-Day Acuvue® Moist Brand Multifocal Contact Lens DEVICE

CONTROL

Control/Test; Test/Control

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Potential subjects must satisfy all of the following criteria to be enrolled in the study:
• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must be at least 40 years of age and not greater than 70 years of age at the time of consent.
• Subjects must own a wearable pair of spectacles if required for their distance vision.
• 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 8 hours per wear day, for 1 month or more duration).
• 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).
• The subject's distance spherical equivalent refraction must be in the range of +1.25 D to +3.75 D in each eye.
• The subject's refractive cylinder must be ≤0.75 D in each eye.
• The subject's ADD power must be in the range of +0.75 D to +2.50 D.
• The subject must have distance best corrected visual acuity of 20/20-3 or better in each eye.

You may not qualify if:

• Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• Currently pregnant or lactating.
• Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
• 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).
• Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
• A history of amblyopia, strabismus or binocular vision abnormality.
• Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, oral phenothiazines, oral/topical/inhaled anticholinergics, systemic/topical corticosteroids.
• Use of any ocular medication, with the exception of rewetting drops.
• History of herpetic keratitis.
• History of irregular cornea.
• History of pathological dry eye.
• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution, sodium fluorescein or non-preserved rewetting drop solutions.
• Clinically significant (Grade 2 or greater) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (4)

Maitland Vision Center

Maitland, Florida, 32751, United States

Location

Advanced Eyecare

Raytown, Missouri, 64133, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Frazier Vision Inc.

Jacksonville, Texas, 75703, United States

Location

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Thomas R Karkkainen.
• Organization: Johnson & Johnson Vision Care, Inc.

tkarkkai@its.jnj.com

1-800-843-2020

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 6, 2019
• Study Start: November 15, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: April 27, 2025
• Results First Posted: April 2, 2021

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)