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Visual AcuityNCT05222880

Evaluation of a Daily Disposable Silicone Hydrogel Multifocal Contact Lens in Myopes and Hyperopes

A study testing JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 12 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

This is a single-masked, single-arm, dispensing clinical trial that will evaluate vision, eye health and fit acceptance. 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 Lenses manufactured in senofilcon A C3
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
12 sitesUnited States
Study dates
6 Jan 2022to 28 Feb 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 at least 40 years of age and not greater than 70 years of age at the time of consent.
  • 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 a minimum of 2 days per week for at least 6 hours per wear day, for 1 month or more duration).
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  • 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".
  • 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

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Be currently pregnant or lactating.
  • Have any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  • Have 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).
  • Have 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.).
  • Have a history of amblyopia, strabismus or binocular vision abnormality.
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  • Use of any of the following medications within 1 week prior to enrollment: oral retinoid, oral tetracyclines, anticholinergics, oral phenothiazines, oral/inhaled corticosteroids. See section 9.1 for further examples.
  • Use of any ocular medication, with the exception of rewetting drops.
  • Have a history of herpetic keratitis.
  • Have a history of irregular cornea.
  • Have a history of pathological dry eye.
  • Have Participated in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  • Be and employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  • Have any known hypersensitivity or allergic reaction to non-preserved rewetting drop solutions or sodium fluorescein.
  • Have 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.
  • Have any current ocular infection or inflammation.
  • Have any current ocular abnormality that may interfere with contact lens wear.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

United States12 sites

  • Birmingham Vision Care

    Bloomfield Hills, Michigan, 48601

  • Vision Optique

    Houston, Texas, 77005

  • Vue Optical Boutique

    Jacksonville, Florida, 32205

  • Stam & Associates Eye Care

    Jacksonville, Florida, 32256

  • Maitland Vision Center - North Orlando Ave

    Maitland, Florida, 32751

  • Eye Associates of New York

    Manhattan, New York, 10022

  • Optometry Group, LLC

    Memphis, Tennessee, 38111

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • Tallahassee Eye Center

    Tallahassee, Florida, 32308

  • Tyler Eye Associates

    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

This is a single-masked, single-arm, dispensing clinical trial that will evaluate vision, eye health and fit acceptance.

Conditions
Visual Acuity
Being tested
JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3

What participants receive

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

  • JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3Device

    TEST Lens

Study groups in NCT05222880
Study groupRoleWhat they receive
TEST LensExperimentalEligible subjects who are habitual soft contact lens wearers will be given the TEST Lens for the duration of the study.
Receives: Device: JJVC Investigational Multifocal Contact Lenses manufactured in senofilcon A C3

What is being measured

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

  1. Binocular logMAR Visual Acuity

    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.

    Measured: 1-Week Follow-up

  2. CLUE Vision Score

    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.

    Measured: 1-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, the 1-week follow-up and any unscheduled visits. 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.

    Measured: Up to 1-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 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.

    Measured: Up to 1-Week Follow-up

Secondary outcomes (4)

  1. CLUE Vision Score

    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.

    Measured: 1-Week Follow-up

  2. CLUE Comfort Score

    Subjective comfort 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 comfort score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined.

    Measured: 1-Week Follow-up

  3. CLUE Handling Score

    Subjective Handling 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 handling score was reported. The pre-specified aim was not to compare comfort between the hyperope and myope subgroups, therefore, comfort scores were reported for both groups combined.

    Measured: 1-Week Follow-up

  4. Proportion of Subject Achieving 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 10. 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.

    Measured: Up to 1-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 posted3 Feb 2022
  2. Study start6 Jan 2022
  3. Primary completion28 Feb 2022
  4. Study completion28 Feb 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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05222880
Sponsor's protocol ID
CR-6477
Status last verified
Apr 2023
First submitted
4 Jan 2022
Last updated
13 Apr 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 Lenses manufactured in senofilcon A C3 in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 12 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 11 inclusion and 17 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 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 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 Apr 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?

Binocular logMAR Visual Acuity (time frame: 1-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 NCT05222880.

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 Apr 2023.

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