Evaluation of the Clinical Performance of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

NCT06377488 | Completed Results FDA Device

• 1 other identifier: CR-6542
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 15

Brief Summary

This will be an open-label, 3-visit, single-arm, dispensing clinical trial to evaluate visual acuity.

Conditions

Visual Acuity

Outcome Measures

Primary Outcomes (6)

• HLHC Binocular logMAR Visual Acuities

  Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made using reduced Guillon-Poling charts. Letter-by-letter results calculated the visual performance score for each chart read. LogMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20. Data from hyperopes and myopes were combined for this outcome since logMAR scores between the two populations are similar.

  2-Week Follow-up

• CLUE Vision Scores

  Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient-experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120. The average CLUE vision score for each sphere stratum (Hyperope and Myope) was reported.

  2-Week Follow-up

• Proportion of Eyes With Absolute Rotation Less Than or Equal to 10 Degrees

  Absolute rotation was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Acceptable absolute rotation was dichotomized into a binary response where Y=1 if absolute rotation was less than or equal to 10 degrees and Y=0 otherwise (absolute rotation greater than 10 degrees). The proportion of eyes with absolute rotation less than or equal to 10 degrees was report for each lens.

  15-minutes after lens insertion

• Proportion of Eyes With Rotational Stability Less Than or Equal to 5 Degrees

  Rotational Stability was assessed for each subject eye using a slit lamp 15-minutes after lens insertion. Rotational Stability was dichotomized into a binary response where Y=1 if Rotational Stability was less than or equal to 5 degrees and Y=0 otherwise (Rotational Stability greater than 5 degrees). The proportion of eyes with Rotational Stability less than or equal to 5 degrees was report for each lens.

  15-minutes after lens insertion

• Proportion of Eyes With Grade 3 or Higher Slit Lamp Findings

  Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at every study visit (baseline, unscheduled visits and 1-week follow-up). The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The proportion of eyes with SLF with grade 3 or higher was reported. Data from the hyperope and myopes group were combined for this outcome since the rate of SFLs grade 3+ is similar for these two populations.

  Up to 2-Week Follow-up

• Proportion of Eyes With Unacceptable Lens Fitting

  Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion at the 1-week follow-up. Lens fit was a binary variable where unacceptable lens fit=1 and acceptable lens fit=0. The proportion of eyes with unacceptable lens fit was reported. Data from the hyperope and myopes group were combined for this outcome since lens fitting characteristics are similar for these two populations.

  Up to 2-Week Follow-up

Secondary Outcomes (4)

• CLUE Vision Scores

  2-Week Follow-up

• CLUE Comfort Scores

  2-Week Follow-up

• CLUE Handling Scores

  2-Week Follow-up

• Proportion of Subject Achieving Optimal Lens Pair in 4 Lenses or Less.

  Up to 1-Week Follow-up

Study Arms (1)

Test Arm

EXPERIMENTAL

Eligible subjects who are habitual soft contact lens wearers will be fit with the TEST lens in both eyes, to wear the lens for a minimum of 6 hours a day, every day, between visits for approximately 2 weeks.

Device: JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter

Interventions

JJVC Investigational Multifocal Toric Contact Lens manufactured in Senofilcon A (C3) material with UV blocker / HEV filter DEVICE

Test Lens

Test Arm

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:
• Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be at least 40 and not more than 70 years of age at the time of screening.
• Own a wearable pair of spectacles if required for their distance vision.
• 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).
• 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".
• 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 +4.25 D.
• The subject's refractive cylinder must be in the range of -1.00 D to -1.75 D in each eye, with the cylinder axes in the range of either 90°±15° or 180°±15°.
• The subject's ADD power must be in the range of +0.75 D to +2.50 D in each eye.
• The subject must have best corrected distance 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:
• The subject must not:
• Be currently pregnant or lactating.
• 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, which are known to interfere with contact lens wear and/or participation in the study.
• Use systemic medications that may interfere with contact lens wear or cause blurred vision. See Section 9.1 for additional details regarding excluded systemic medications.
• Currently use ocular medication (with the exception of rewetting drops).
• Have any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
• Have had any previous, or have any planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, cataract surgery, retinal surgery, etc.).
• Have had previous eyelid injuries, surgeries or procedures which are known to have caused abnormal eyelid position or movement, by self-report.
• Have participated in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• Be an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• Have a history of amblyopia or strabismus, by self-report.
• Have a history of herpetic keratitis, by self-report.
• Have ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion.
• Have any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (15)

Dr. James Weber & Associates, PA - City Square Blvd

Jacksonville, Florida, 32218, United States

Location

Stam & Associates Eye Care

Jacksonville, Florida, 32256, United States

Location

Omega Vision Center

Longwood, Florida, 32779, United States

Location

Maitland Vision Center - North Orlando Ave

Maitland, Florida, 32751, United States

Location

Mid-State Eye

Clinton, Illinois, 61727, United States

Location

Kannarr Eye Care

Pittsburg, Kansas, 66762, United States

Location

Birmingham Vision Care

Bloomfield Hills, Michigan, 48301, United States

Location

Center for Ophthalmic and Vision Research/Eye Associates of New York

Manhattan, New York, 10022, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

ProCare Vision Centers

Granville, Ohio, 43023, United States

Location

Luxe Vision and Optical

Powell, Ohio, 43065, United States

Location

Dr. David W. Ferris & Associates

Warwick, Rhode Island, 02888, United States

Location

Optometry Group, LLC

Memphis, Tennessee, 38111, United States

Location

Tyler Eye Associates

Tyler, Texas, 75703, United States

Location

New River Vision Care

Oak Hill, West Virginia, 25901, United States

Location

Results Point of Contact

• Title: Johnson & Johnson Vision Care Study Contact
• Organization: Johnson & Johnson Vision Care

RFrankl1@its.jnj.com

1-800-843-2020

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 22, 2024
• Study Start: April 22, 2024
• Primary Completion: June 24, 2024
• Study Completion: June 24, 2024
• Last Updated: October 28, 2025
• Results First Posted: July 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (15)