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Visual AcuityNCT04534517

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

A study testing JJV Investigational Multifocal Contact Lens and ACUVUE OASYS® with HYDRACLEAR® PLUS in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
JJV Investigational Multifocal Contact Lens and ACUVUE OASYS® with HYDRACLEAR® PLUS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
119 participants
Where
11 sitesUnited States
Study dates
7 Aug 2020to 29 Sep 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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. wears lenses a minimum of 2 days per week for at least 6 hours per wear day, for 1 month of 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).
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  • 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.
  • 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.

Who cannot join

  • 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, dacryocystorhinostomy, peripheral iridotomy/iridectomy, cataract surgery, retinal surgery, etc.).
  • A history of amblyopia, strabismus or binocular vision abnormality.
  • History of glaucoma, macular degeneration, recurrent corneal erosions, recurrent styes, herpetic keratitis, irregular cornea or pathological dry eye.
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  • Use of any of the following medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, corticosteroids.
  • Use of any ocular medication, with the exception of rewetting drops.
  • 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.
  • Any current ocular infection or inflammation.
  • Any current ocular abnormality that may interfere with contact lens wear.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • VisionPoint Eye Center

    Bloomington, Illinois, 61704

  • ProCare Vision Centers

    Granville, Ohio, 43023

  • Dr. James Weber & Associates, PA

    Jacksonville, Florida, 32205

  • Sabal Eye Care

    Longwood, Florida, 32779

  • Maitland Vision Center

    Maitland, Florida, 32751

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • Advanced Eyecare

    Raytown, Missouri, 64133

  • VisualEyes

    Roswell, Georgia, 30076

  • Frazier Vision Inc.

    Tyler, Texas, 75703

  • Sacco Eye Group

    Vestal, New York, 13850

  • Dr. David W. Ferris & Associates

    Warwick, Rhode Island, 02888

Other trials in United States

About this study

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.

Conditions
Visual Acuity
Being tested
JJV Investigational Multifocal Contact Lens, ACUVUE OASYS® with HYDRACLEAR® PLUS

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JJV Investigational Multifocal Contact LensDevice

    TEST Lens

  • ACUVUE OASYS® with HYDRACLEAR® PLUSDevice

    Also called senofilcon A

    The spherical test lens was used in the troubleshooting steps only for low ADD subjects who have reported a distance vision complaint.

Study groups in NCT04534517
Study groupRoleWhat they receive
TEST LensExperimentalEligible subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age will be recruited. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Receives: Device: JJV Investigational Multifocal Contact Lens; Device: ACUVUE OASYS® with HYDRACLEAR® PLUS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vision Scores

    Overall vision scores were 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.

    Measured: 2-Week Follow-up

  2. Visual Performance LogMAR

    Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4m), intermediate (64cm) and near (40cm) under high luminance high contrast lighting condition using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 to 7.9 EV (394-597 lux). For Distance (4m), the acceptable range for the chart luminance was 10.5-10.7 EV (181 208 cd/m2). For Intermediate (64cm) and Near (40cm), the acceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). Letter-by-letter results calculated the visual performance score for each chart read. A logMAR score closer to zero, or below zero, indicates 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.

    Measured: 2-Week Follow-up

  3. Proportion of Eyes With Unacceptable Lens Fitting

    Contact lens fitting acceptance was assessed for each subject eye using a biomicroscope post lens insertion and the 2-week follow-up. Lens fit was a binary variable where acceptable lens fit=1 and unacceptable 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 characteristerics are similar for these two populations.

    Measured: Up to 2-Week Follow-up

  4. 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 2-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 SLFs grade 3 + is similar for both populations.

    Measured: Up to 2-Week Follow-up

Secondary outcomes (1)

  1. Proportion of Eyes That Achieved Optimal Lens Pair in 4 Lenses or Less

    The number of lenses to achieve the optimal pair for each subject was calculated as the original pair (2) plus all the required modifications to reach the optimal pair. In this study the minimum number of lenses per subject used was 2 where the maximum possible number of lenses used was 12. The data was dichotomized as Y=1 if the subject was able to achieve optimal lens pair in 4 lenses or lenses or less and 0 otherwise. A lens modification was performed if the subject reports unsatisfactory vision or was unable to obtain 20/30 distance visual acuity in both eyes. If the subject reported satisfactory vision with the lenses a modification was not required. However, based upon the investigator's findings on the measured visual acuity and/or over-refraction a modification may have been performed. Data for the hyperope and myope groups were combined for this endpoint since the number of lenses needed to optimize vision is indpendent of which group a subject belongs to.

    Measured: Up to 2-Week Follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Sep 2020
  2. Study start7 Aug 2020
  3. Primary completion29 Sep 2020
  4. Study completion29 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
119 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04534517
Sponsor's protocol ID
CR-6400
Status last verified
Dec 2021
First submitted
27 Aug 2020
Last updated
13 Jan 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Questions about this trial

What is this clinical trial studying?

A study testing JJV Investigational Multifocal Contact Lens and ACUVUE OASYS® with HYDRACLEAR® PLUS in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vision Scores (time frame: 2-Week Follow-up). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04534517.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.

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