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Visual AcuityNCT04995055

Evaluation of Multifocal Contact Lens Designs With and Without an HEV Blocker on Visual Function

A study testing JJVC Investigational Multifocal Contact Lens TEST Lens and ACUVUE® OASYS Multifocal in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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

This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing clinical trial to characterize the effects of an HEV-Blocker on several measures of visual function in a presbyopic population. 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?
JJVC Investigational Multifocal Contact Lens TEST Lens and ACUVUE® OASYS Multifocal
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteUnited States
Study dates
25 Oct 2021to 14 Apr 2022
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

  • 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 between at least 40 and not more than 70 years of age at the time of screening.
  • Possess a wearable pair of spectacles that provide correction for distance vision.
  • 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 of more duration).
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  • 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".
  • The subject must have normal color perception as evidenced by reading 17 out of the first 21 Ishihara plates correctly.
  • The subject's distance spherical equivalent of their refraction must be in the range of -1.00 D to -4.00 D.
  • 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 in each eye.
  • The subject must have best corrected distance visual acuity of 20/20-3 or better in each eye.

Who cannot join

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Be currently pregnant or lactating.
  • 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.
  • Use of any of the following oral medications within 1 week prior to enrollment: oral retinoids, oral tetracyclines, oral phenothiazines, anticholinergics, oral/inhaled steroids, oral phosphodiesterase type 5 inhibitors, interferon alfa, antimycobacterial antibiotics, and nitroimidazole antibiotics. See Section 9.1 for additional details regarding excluded systemic medications.
  • Any current use of ocular medication with the exception of rewetting drops.
  • Any known hypersensitivity or allergic reaction to single use preservative free rewetting drops or sodium fluorescein.
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  • Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK dacryocystorhinostomy, cataract surgery, retinal surgery, peripheral iridotomy/iridectomy, etc.).
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  • Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  • A history of amblyopia, strabismus or binocular vision abnormality.
  • History of optic nerve or retinal disease or trauma
  • Abnormal color vison.
  • Any 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, or corneal distortion
  • Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA scale.
  • Any current ocular infection or inflammation.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Georgia

    Athens, Georgia, 30602

Other trials in United States

About this study

This is a single-masked, bilateral, controlled, randomized, 2x2 crossover, non-dispensing clinical trial to characterize the effects of an HEV-Blocker on several measures of visual function in a presbyopic population.

Conditions
Visual Acuity
Being tested
JJVC Investigational Multifocal Contact Lens TEST Lens, ACUVUE® OASYS Multifocal

What participants receive

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

  • JJVC Investigational Multifocal Contact Lens TEST LensDevice

    TEST Lens

  • ACUVUE® OASYS MultifocalDevice

    CONTROL Lens

Study groups in NCT04995055
Study groupRoleWhat they receive
Period 1ExperimentalEligible subjects will be randomly assigned to contact lens wear sequence TEST/CONTROL in a bilateral fashion.
Receives: Device: JJVC Investigational Multifocal Contact Lens TEST Lens; Device: ACUVUE® OASYS Multifocal
Period 2ExperimentalEligible subjects will be randomly assigned to contact lens wear sequence CONTROL/ TEST in a bilateral fashion.
Receives: Device: JJVC Investigational Multifocal Contact Lens TEST Lens; Device: ACUVUE® OASYS Multifocal

What is being measured

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

  1. Starburst Diameter (mm)

    The starburst diameter (mm) was measured each subject binocularly. Starburst diameter was quantified by the horizontal spread of the spokes emerging from the center of a small, point-like stimulus. A calibrated custom-made micrometer (two sides with reverse threading) was used to spread two posts out from a central mid-point. The posts attach to a custom-designed ruler that indicates the lateral spread of the starburst. Measurements for this metric are positive. Smaller diameter indicates better lens performance. The average diameter (mm) for each lens type was reported by period.

    Measured: 30-minutes post lens insertion

  2. Halos Diameter (mm)

    Halo diameter (mm) was quantified and measured using the same micrometer as for starbursts diameter (mm). The Halo diameter (mm) was measured each subject binocularly. Measurements for halo diameter are positive, where smaller values indicate better performance. The average diameter (mm) for each lens type.

    Measured: 30-minutes post lens insertion

  3. Glare Disability Threshold

    Glare disability threshold was collected binocularly for each subject. Subjects were exposed to a target stimulus for 2 seconds; before the measurement was taken the annulus was set to a level below that which would cause the target stimulus to be veiled. The experimenter would then adjust the intensity of the annulus until subjects could no longer see the target stimulus. Subjects would indicate this by pressing a buzzer. Glare disability thresholds take on positive values, where higher values indicate better lens performance. The average glare disability level (change in log relative energy) for each lens type was reported.

    Measured: 30-minutes post lens insertion

Secondary outcomes (4)

  1. Glare Discomfort (mm)

    The Glare discomfort was evaluated by calculating the change in height of the palpebral fissure measured while the participant views the mid-wave central grating target, compared to the maximal squint during a 5-second Photostress exposure induced by a solid, 10-degree broadband field, which completely obscures the target (~10-deg diameter). Both eyes were recorded and averaged, to produce an average palpebral fissure height before and during the Photostress exposure. Glare discomfort can take on negative and positive values, where smaller values indicate better lens performance. The average glare discomfort (change in palpebral fissure height) for each lens type was reported.

    Measured: 30-minutes post lens insertion

  2. Heterochromatic Contrast Threshold (HCT)

    Using the same optical bench set-up described Glare Disability Threshold, to measure HCT, participants viewed the mid-wave (580 nm) grating target presented on presented on a short wave (460 nm) "sky-light background." The intensity of the background was adjusted, until the participant was no longer able to resolve the grating target. The log relative energy of the background needed to obscure the central target was recorded as HCT. Heterochromatic contrast thresholds are positive values, where higher values indicate better lens performance. The average threshold each lens type was reported.

    Measured: 30-minutes post lens insertion

  3. Two-Point Threshold (mm) With 403nm Filter

    To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type and period.

    Measured: 30-minutes post lens insertion

  4. Two-Point Threshold (mm) Without 403nm Filter

    To create the two-point threshold stimulus, a single point- source like stimulus was spread into two distinct points of light, using a custom-built, collapsible light baffle. The two-point threshold was quantified as the minimum distance (mm) at which a participant could detect two distinct points of light, separated by a small black space. Measurements for this metric are positive. Smaller distances indicate better lens performance. The average distance for each lens type.

    Measured: 30-minutes post lens insertion

Timeline

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

  1. First posted6 Aug 2021
  2. Study start25 Oct 2021
  3. Primary completion14 Apr 2022
  4. Study completion14 Apr 2022

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
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04995055
Sponsor's protocol ID
CR-6391
Status last verified
May 2023
First submitted
29 Jul 2021
Last updated
6 Jun 2023
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 JJVC Investigational Multifocal Contact Lens TEST Lens and ACUVUE® OASYS Multifocal in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 1 site 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 12 inclusion and 16 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 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 6 Jun 2023). 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?

Starburst Diameter (mm) (time frame: 30-minutes post lens insertion). The study lists 3 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 NCT04995055.

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 6 Jun 2023.

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