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Visual AcuityNCT04531241

Clinical Evaluation of Senofilcon A Contact Lenses Using a Novel Manufacturing Technology

A study testing ACUVUE® OASYS 1-DAY in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 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 study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods. Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
ACUVUE® OASYS 1-DAY
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
136 participants
Where
7 sitesUnited States
Study dates
5 Aug 2020to 25 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 18 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.
  • Appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
  • The subject must be a habitual and adapted wearer of daily disposable contact lenses in both eyes (at least 1 month of daily wear).
  • The subject must have normal eyes (i.e., no ocular medications or infections of any type).
  • The subject's required spherical contact lens prescription must be in the range of -0.50 to -3.25 and -3.75 to -6.00 D in each eye.
  • The subject's refractive cylinder must be ≤0.75D in each eye, if present
  • The subject must have best corrected visual acuity of 20/25 or better in each eye.

Who cannot join

  • Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
  • Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear. (at the discretion of the investigator)
  • Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • Any ocular infection.
  • Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
  • Monovision or multi-focal contact lens correction.
Show all 15Show fewer
  • Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
  • History of binocular vision abnormality or strabismus.
  • Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
  • Suspicion of or recent history of alcohol or substance abuse.
  • History of serious mental illness.
  • History of seizures.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
  • Any 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, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
  • Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale.

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • VisionPoint Eye Center

    Bloomington, Illinois, 61704

  • ProCare Vision Centers

    Granville, Ohio, 43023

  • Vue Optical Boutique

    Jacksonville, Florida, 32205

  • Maitland Vision Center

    Maitland, Florida, 32751

  • EyeCare Professionals of Powell

    Powell, Ohio, 43065

  • Tallahassee Eye Center

    Tallahassee, Florida, 32308

  • Frazier Vision, Inc.

    Tyler, Texas, 75703

Other trials in United States

About this study

This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear bilaterally both Test and Control lenses in a random order for 1-week each as a daily disposable modality with a wash-out period of 1 week between the wearing periods.

Conditions
Visual Acuity
Being tested
ACUVUE® OASYS 1-DAY

What participants receive

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

  • ACUVUE® OASYS 1-DAYDevice

    Also called TEST

    senofilcon A contact lenses made with a novel manufacturing technology

  • ACUVUE® OASYS 1-DAYDevice

    Also called CONTROL

    senofilcon A contact lenses made with the current manufacturing technology

Study groups in NCT04531241
Study groupRoleWhat they receive
Test/ControlExperimentalEligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Test/Control.
Receives: Device: ACUVUE® OASYS 1-DAY
Control/TestExperimentalEligible subjects that are habitual wearers of daily disposable contact lenses in both eyes will be randomly assigned to sequence, Control/Test.
Receives: Device: ACUVUE® OASYS 1-DAY

What is being measured

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

  1. Overall CLUE Comfort

    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.

    Measured: 1-Week Follow-up

  2. Overall CLUE 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: 1-Week Follow-up

Secondary outcomes (2)

  1. Visual Performance

    Visual performance was calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This was evaluated under both high luminance/low contrast conditions and low luminance/high contrast conditions at 4 meters from Early Treatment Diabetic Retinopathy Study (ETDRS) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For high illumination, the room was required to be >400 lux with low contrast charts. For low illumination, the room was required to be <2.5 lux. 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. Average Daily Wear Time (in Hours)

    Average daily wear time was calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day, at 1-Week Follow up evaluation.

    Measured: 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 posted28 Aug 2020
  2. Study start5 Aug 2020
  3. Primary completion25 Sep 2020
  4. Study completion25 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
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
136 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04531241
Sponsor's protocol ID
CR-6417
Status last verified
Nov 2021
First submitted
26 Aug 2020
Last updated
14 Dec 2021
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 ACUVUE® OASYS 1-DAY in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 7 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 8 inclusion and 15 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 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 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 Dec 2021). 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 CLUE Comfort (time frame: 1-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 NCT04531241.

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 Dec 2021.

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