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Visual AcuityNCT03586648

Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase 2

A study testing senofilcon A Multifocal, senofilcon A Sphere and etafilcon A Multifocal in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 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, randomized-controlled, dispensing clinical trial. A total of approximately 60 eligible hyperopic subjects will be targeted to complete this study. 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?
senofilcon A Multifocal, senofilcon A Sphere and etafilcon A Multifocal
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
6 sitesUnited States
Study dates
14 Jun 2018to 20 Aug 2018
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 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.
  • The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
  • The subject must be between 40 and 70 years of age (inclusive).
  • The subject's distance spherical equivalent refraction must be in the range of -1.25 D to -3.75 D in each eye.
  • The subject's refractive cylinder must be ≤0.75 D in each eye.
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  • 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.
  • Subjects must own a wearable pair of spectacles if required for their distance vision.
  • The subject must 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).
  • The subject must 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".

Who cannot join

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:
  • Currently pregnant or lactating.
  • Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
  • 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).
  • Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
  • Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
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  • Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, cataract surgery, retinal surgery, etc.).
  • A history of amblyopia, strabismus or binocular vision abnormality.
  • Any current ocular infection or inflammation.
  • Any current ocular abnormality that may interfere with contact lens wear.
  • Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral antihistamines (e.g., Chlor-Trimeton, and Benadryl), systemic steroids.
  • Use of any ocular medication, with the exception of rewetting drops.
  • History of herpetic keratitis.
  • Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
  • Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
  • Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution or Eye-Cept® rewetting drop solution.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Western Reserve Vision Care

    Beechwood, Ohio, 44122

  • Procare Vision Center

    Granville, Ohio, 43023

  • Dr. James E. Weber

    Jacksonville, Florida, 32205

  • Maitland Vision Center

    Maitland, Florida, 32751

  • Wayne Golden, OD

    Sarasota, Florida, 34232

  • Golden Optometric Group

    Whittier, California, 90606

Other trials in United States

About this study

Official title: Clinical Evaluation of a Reusable Multifocal Optical Design in a Presbyopic Population Phase II

This is a single-masked, randomized-controlled, dispensing clinical trial. A total of approximately 60 eligible hyperopic subjects will be targeted to complete this study.

Conditions
Visual Acuity
Being tested
senofilcon A Multifocal, senofilcon A Sphere, etafilcon A Multifocal, etafilcon A Sphere

What participants receive

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

  • senofilcon A MultifocalDevice

    Also called JJVC Investigational Multifocal Contact Lens

    TEST Lens

  • senofilcon A SphereDevice

    Also called ACUVUE OASYS 2-WEEK with HYDRACLEAR PLUS

    TEST Lens Sphere

  • etafilcon A MultifocalDevice

    Also called 1-Day Acuvue Moist Brand Multifocal Contact Lens

    CONTROL Lens

  • etafilcon A SphereDevice

    Also called 1-Day Acuvue Moist Brand Contact Lens

    CONTROL Lens Sphere

Study groups in NCT03586648
Study groupRoleWhat they receive
Test/ControlExperimentalHyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Test/Control. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Receives: Device: senofilcon A Multifocal; Device: senofilcon A Sphere; Device: etafilcon A Multifocal; Device: etafilcon A Sphere
Control/TestExperimentalHyperopic subjects who are habitual soft contact lens wearers between the ages of 40 and 70 years of age, will be randomized to sequence Control/Test. Alternative Spherical lenses will be used if optimization cannot be achieved with the Multifocal lenses.
Receives: Device: senofilcon A Multifocal; Device: senofilcon A Sphere; Device: etafilcon A Multifocal; Device: etafilcon A Sphere

What is being measured

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

  1. Vision Scores

    Overall quality of 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. Vision Scores Comparison Between Test and Control

    Overall quality of 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

Timeline

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

  1. First posted13 Jul 2018
  2. Study start14 Jun 2018
  3. Primary completion20 Aug 2018
  4. Study completion20 Aug 2018

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
71 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03586648
Sponsor's protocol ID
CR-6267
Status last verified
Apr 2020
First submitted
2 Jul 2018
Last updated
13 May 2020
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 senofilcon A Multifocal, senofilcon A Sphere and etafilcon A Multifocal in people with Visual Acuity, run by Johnson & Johnson Vision Care, Inc. at 6 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 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 13 May 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 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 May 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?

Vision Scores (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 NCT03586648.

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 May 2020.

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