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

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ClinicalTrials.gov Identifier: NCT03962790
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

Brief Summary:
This study is a multi-site, randomized, double-masked, 2×2 crossover design, 1-week dispensing study. Subjects will wear both Test and Control lenses in each eye 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.

Condition or disease Intervention/treatment Phase
Visual Acuity Device: 1-DAY ACUVUE® MOIST Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology
Estimated Study Start Date : May 28, 2019
Estimated Primary Completion Date : July 5, 2019
Estimated Study Completion Date : July 5, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Test/Control
Eligible subjects that are habitual wearers of hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test).
Device: 1-DAY ACUVUE® MOIST
etafilcon A contact lenses made with a new manufacturing technology
Other Name: Test

Device: 1-DAY ACUVUE® MOIST
etafilcon A contact lenses made with the current manufacturing technology
Other Name: Control

Experimental: Control/Test
Eligible subjects that are habitual wearers of hydrogel daily disposable contact lenses in both eyes will be randomly assigned to one of two sequences, (Test/Control) or (Control/Test).
Device: 1-DAY ACUVUE® MOIST
etafilcon A contact lenses made with a new manufacturing technology
Other Name: Test

Device: 1-DAY ACUVUE® MOIST
etafilcon A contact lenses made with the current manufacturing technology
Other Name: Control




Primary Outcome Measures :
  1. CLUE Comfort Score [ Time Frame: approximately 9 days of contact lens wear ]
    Subjective assessment of comfort will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.

  2. CLUE Vision Score [ Time Frame: approximately 9 days of contact lens wear ]
    Subjective assessment of vision will be performed using the Contact Lens User ExperienceTM (CLUE) questionnaire. CLUE is a validated patient reported outcomes (PRO) questionnaire used to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a US contact-lens wearing population between 18 and 65 years of age. CLUE composite scores are derived using Item Response Theory (IRT) and follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response. A 5-point increase in an average CLUE score translates into 10% shift in the distribution of scores for the population of soft disposable contact lens wearers.


Secondary Outcome Measures :
  1. Average daily wear time (in hours) [ Time Frame: approximately 9 days of contact lens wear ]
    Average daily wear time will be calculated as the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.

  2. Visual performance [ Time Frame: approximately 9 days of contact lens wear ]
    Visual performance will be calculated as monocular contact lens-corrected distance visual acuity using a logMAR visual acuity scale. This will be 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Potential subjects must satisfy all of the following criteria to be enrolled in the study:

    1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
    2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
    3. Must be at least 18 and not more than 70 years of age (including 70) at the time of screening.
    4. The subject must be a habitual and adapted wearer of hydrogel daily disposable brand contact lenses in both eyes (at least 1 month of daily wear).
    5. The subject must have normal eyes (i.e., no ocular medications or infections of any type).
    6. The subject's required spherical contact lens prescription must be in the range of -0.50 to -6.00 D in each eye.
    7. The subject's refractive cylinder must be < 0.75D in each eye.
    8. The subject must have best corrected visual acuity of 20/25 or better in each eye.

      Exclusion Criteria:

  • Potential subjects who meet any of the following criteria will be excluded from participating in the study:

    1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
    2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
    3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
    4. Any ocular infection.
    5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
    6. Monovision or multi-focal contact lens correction.
    7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
    8. History of binocular vision abnormality or strabismus.
    9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
    10. Suspicion of or recent history of alcohol or substance abuse.
    11. History of serious mental illness.
    12. History of seizures.
    13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
    14. 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
    15. 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
    16. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03962790


Contacts
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Contact: Brian Pall, OD, MS, FAAO 1-800-843-2020 bpall@its.jnj.com

Locations
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United States, Florida
Maitland Vision Center Not yet recruiting
Maitland, Florida, United States, 32751
United States, Illinois
Eyecare Associates, LLP Not yet recruiting
Bloomington, Illinois, United States, 61701
United States, New York
Manhattan Vision Associates Not yet recruiting
New York, New York, United States, 10022
Sacco Eye Group Not yet recruiting
Vestal, New York, United States, 13850
United States, Ohio
Eyecare Professionals of Powell Not yet recruiting
Powell, Ohio, United States, 43065
United States, Texas
Frazier Vision Not yet recruiting
Tyler, Texas, United States, 75703
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.

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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT03962790     History of Changes
Other Study ID Numbers: CR-6324
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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
URL: http://yoda.yale.edu

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes