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Visual AcuityNCT04974697

Evaluation of Daily Disposable Silicone Hydrogel Multifocal Toric Contact Lenses

A study testing JJVC Investigational Multifocal Toric Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 8 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 study is a bilateral, single-masked, single-arm, 4-visit dispensing study. There will be one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical performance of investigational… 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 Toric Contact Lens
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
8 sitesUnited States
Study dates
19 Jul 2021to 29 Oct 2021
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 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).
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  • 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 +3.75 D.
  • The subject's refractive cylinder must be -1.00 D to -1.50 D in each eye, with the cylinder axes in the range of 90°±30°.
  • 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.
  • 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, by self-report, 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.
  • 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.
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

United States8 sites

  • Birmingham Vision Care

    Bloomfield Township, Michigan, 48301

  • Stam & Associates Eye Care

    Jacksonville, Florida, 32256

  • VRC-West

    Jacksonville, Florida, 32256

  • Maitland Vision Center

    Maitland, Florida, 32751

  • Eye Associates of New York

    New York, New York, 10022

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762

  • Tyler Eye Associates

    Tyler, Texas, 75703

  • Sacco Eye Group

    Vestal, New York, 13850

Other trials in United States

About this study

The study is a bilateral, single-masked, single-arm, 4-visit dispensing study. There will be one study treatment, with the subject being dispensed lenses for 6 to 8 days, then lens power will be optimized (if necessary) and dispensed for a further 2 weeks to assess the clinical performance of investigational multifocal toric contact lenses.

Conditions
Visual Acuity
Being tested
JJVC Investigational Multifocal Toric Contact Lens

What participants receive

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

  • JJVC Investigational Multifocal Toric Contact LensDevice

    TEST

Study groups in NCT04974697
Study groupRoleWhat they receive
JJVC Investigational Multifocal Toric Contact LensExperimentalEligible subjects that are adapted contact lens wearers with presbyopia, ametropia (hyperopia or myopia) and astigmatism will be dispensed the study lens in a bilateral fashion.
Receives: Device: JJVC Investigational Multifocal Toric Contact Lens

What is being measured

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

  1. Overall Vision

    Overall 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.

    Measured: 2-Week Follow-up

  2. LogMAR Visual Acuity

    Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m),intermediate (64 cm) and near (40 cm) 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 and 7.9 EV (394-597 lux). For Distance (4 m), 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. Hyperopes and myopes were combined based on historical data for subjects in this study with regard to visual performance logMAR.

    Measured: 2-Week Follow-up

Secondary outcomes (3)

  1. Change From Baseline CLUE Vision Score

    Overall 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 change from baseline was calculated as the 2 week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.

    Measured: Up to 2-Week Follow-up

  2. Change From Baseline CLUE Comfort Score

    Overall 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 change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.

    Measured: Up to 2-Week Follow-up

  3. Change From Baseline CLUE Handling Score

    Overall 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 change from baseline was calculated as the 2- week follow-up scores minus baseline scores. Change from baseline scores range from -120 to 120, where higher change from baseline scores indicate better performance. The average change from baseline was reported.

    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 posted23 Jul 2021
  2. Study start19 Jul 2021
  3. Primary completion29 Oct 2021
  4. Study completion29 Oct 2021

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
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04974697
Sponsor's protocol ID
CR-6435
Status last verified
Oct 2022
First submitted
19 Jul 2021
Last updated
14 Nov 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 JJVC Investigational Multifocal Toric Contact Lens in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 8 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 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 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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 14 Nov 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?

Overall Vision (time frame: 2-Week Follow-up). The study lists 2 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 NCT04974697.

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 14 Nov 2022.

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