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Visual AcuityNCT03742271

Evaluation of Senofilcon A With New UV-blocker on a Neophyte Population

A study testing senofilcon A 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

This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Visual Acuity
What is being tested?
senofilcon A
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
130 participants
Where
11 sitesUnited States
Study dates
30 Oct 2018to 31 Mar 2019
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 39 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:
  • 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.
  • Between 18 and 39 (inclusive) years of age at the time of screening.
  • They are a contact lens 'neophyte'. In this work 'neophyte' is taken to mean any subject who has never been dispensed contact lenses. A subject who had taken part in a non-dispensing clinical study or had been fitted with contact lenses in practice but never went on to actually wear the lenses, is also classified as a 'neophyte'.
  • Habitual spectacles must have resulted from an eye exam within the past six months.
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  • The subject must have worn the updated spectacles for at least two weeks.
  • Be a current wearer of prescription spectacles that provide corrected monocular visual acuity of 20/25 or better in each eye.
  • The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 D (inclusive) in each eye.
  • The subject's refractive cylinder must be -1.00 D or less in each eye.
  • Have spherocylindrical best corrected distance Snellen visual acuity of 20/25 or better in each eye.

Who cannot join

  • Potential subjects who meet any of the following criteria will be excluded from participating
  • Currently pregnant or lactating.
  • Any active or ongoing 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 systemic medications that have a high likelihood to interfere with contact lens wear (estrogens, antihistamines, anticholinergics, beta-blockers, and psychotropics).
  • Any current use of ocular medication.
  • Any known hypersensitivity or allergic reaction to any ingredient in Opti-Free PureMoist.
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  • Any previous or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
  • 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 4 slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA slit lamp classification scale.
  • Binocular vision abnormality or strabismus.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • ABQ Eye Care

    Albuquerque, New Mexico, 87109

  • ProCare Vision Centers

    Granville, Ohio, 43023

  • Georgia Center for Sight

    Greensboro, Georgia, 30642

  • Vue Optical Boutique

    Jacksonville, Florida, 32205

  • Atlantic Eye Institute

    Jacksonville Beach, Florida, 32250

  • Sabal Eye Care

    Longwood, Florida, 32792

  • Baker Vision Care

    Macclenny, Florida, 32063

  • Eyecare Professionals of Powell

    Powell, Ohio, 43065

  • Advanced Eyecare

    Raytown, Missouri, 64133

  • Frazier Vision Inc.

    Tyler, Texas, 75703

  • Sacco Eye Group

    Vestal, New York, 13850

Other trials in United States

About this study

This is a 5-visit, single-arm, open-label, dispensing study. Each subject will be bilaterally fit with the test article for approximately 4 weeks of reusable daily wear with lens replacement occurring 2-weeks after initial dispensing. After 4 weeks of study lens wear, subjects will return to their habitual spectacles for one week.

Conditions
Visual Acuity
Being tested
senofilcon A

What participants receive

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

  • senofilcon ADevice

    TEST Lens

Study groups in NCT03742271
Study groupRoleWhat they receive
senofilcon AExperimentalSubjects that are habitual spectacle wearers that have never worn contact lenses and have had an eye exam and an updated spectacle prescription in the last 6 months will be enrolled and fitted into the senofilcon A TEST Lens for a total period of 4 weeks.
Receives: Device: senofilcon A

What is being measured

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

  1. Acceptable Lens Fitting

    Acceptable fit is determined by the eye care practitioner (ECP/investigator) and includes the following criteria; (1) physiological responses (No Grade 3 or higher slit lamp findings), (2) mechanical lens fitting (no unacceptable lens fitting in either eye), (3) subjects' assessment of comfort, vision and handling.

    Measured: 4-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 posted15 Nov 2018
  2. Study start30 Oct 2018
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

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
130 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03742271
Sponsor's protocol ID
CR-6241
Status last verified
Feb 2020
First submitted
13 Nov 2018
Last updated
13 Mar 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A 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 11 inclusion and 11 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 Mar 2020. 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 Mar 2020). 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?

Acceptable Lens Fitting (time frame: 4-Week Follow-up). 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 NCT03742271.

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 Mar 2020.

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