MiSight 1 Day Safety Post-Approval Study

Last updated: October 17, 2024
Sponsor: Coopervision, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Myopia

Treatment

MiSight 1 Day

Clinical Study ID

NCT05285527
PAS002
  • Ages 8-12
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Be between 8 and 12 years of age inclusive at the time of enrollment.

  2. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baselinebetween -0.50 D and -7.00 D inclusive (at the corneal plane).

  3. Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally

  4. Free of ocular disease or abnormalities (including any corneal scar)

  5. The parent/guardian must be capable of comprehending the nature of the study andconsent to the use and release of their child's de-identified health care encounterdata to be used for purposes of this study. Assent will be obtained from the childin a manner specified by the IRB.

  6. Parent/Guardian must sign the Release of Medical Records associated with theoutcomes of interest identified from claims data.

  7. Interested in wearing contact lenses for approximately 10 hours per day and 6 daysper week.

  8. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40or better) eyeglasses.

Exclusion

Exclusion Criteria:

  1. Acute and subacute inflammation or infection of the anterior chamber of the eye.

  2. Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, oreyelids.

  3. Severe insufficiency of lacrimal secretion (dry eyes).

  4. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.

  5. Any systemic disease that may affect the eye or be exaggerated by wearing contactlenses.

  6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggeratedby wearing contact lenses or use of contact lens solutions.

  7. Any active corneal infection (bacterial, fungal, or viral).

  8. If eyes are red or irritated.

  9. The patient is unable to follow lens handling and wear regimen or unable to obtainassistance to do so.

  10. In addition to the labeling contraindications, children who are under medicationthat would interfere with contact lens wear, or who are using any pharmaceuticalsfor control of myopia will not be included in the study.

Study Design

Total Participants: 2400
Treatment Group(s): 1
Primary Treatment: MiSight 1 Day
Phase:
Study Start date:
August 15, 2022
Estimated Completion Date:
May 30, 2027

Study Description

This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.

Connect with a study center

  • Experts on Sight LLC.

    Gilbert, Arizona 85297
    United States

    Active - Recruiting

  • Centerton Family Eyecare

    Centerton, Arkansas 72719
    United States

    Active - Recruiting

  • University of California, Berkeley University Eye Center

    Berkeley, California 94720
    United States

    Active - Recruiting

  • Golden Vision Cupertino Optometry

    Cupertino, California 95014
    United States

    Active - Recruiting

  • Vision Golden Cupertino Optometry

    Cupertino, California 95014
    United States

    Active - Recruiting

  • Boghossian Vision

    Danville, California 94506
    United States

    Active - Recruiting

  • Iron Horse Optometric Group

    Dublin, California 94568
    United States

    Active - Recruiting

  • Capitol Eye Care Center Optometry

    Fremont, California 94536
    United States

    Active - Recruiting

  • Irvine Eye Physicians and Surgeons Inc

    Irvine, California 92618
    United States

    Active - Recruiting

  • Total Vision Golden Milpitas Optometry

    Milpitas, California 95035
    United States

    Site Not Available

  • Elsa Pao OD, Inc

    Oakland, California 94607
    United States

    Active - Recruiting

  • Almaden Family Optometric Center

    San Jose, California 95120
    United States

    Active - Recruiting

  • Perfect Pair Optometry

    San Jose, California 95118
    United States

    Active - Recruiting

  • Children's Eye Physicians

    Centennial, Colorado 80112
    United States

    Active - Recruiting

  • Eye Physicians & Surgeons, PC

    Milford, Connecticut 06460
    United States

    Active - Recruiting

  • Planet Vision Eyecare

    Lake Worth, Florida 33467
    United States

    Active - Recruiting

  • Marino Eye Care

    Miami, Florida 33156
    United States

    Active - Recruiting

  • Vision Source Oviedo, INC

    Oviedo, Florida 32765
    United States

    Active - Recruiting

  • Dau Family Eye Care

    Saint Johns, Florida 32259
    United States

    Site Not Available

  • Gulf Coast Eye Center

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • Dau Family Eye Care

    St. Johns, Florida 32259
    United States

    Active - Recruiting

  • Weston Contact Lens Institute LLC

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Lurie Childrens

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Lyons Family Eye Care P.C.

    Chicago, Illinois 60657
    United States

    Active - Recruiting

  • Darien Eye Specialists

    Darien, Illinois 60561
    United States

    Active - Recruiting

  • Carillon Vision Care

    Glenview, Illinois 60025
    United States

    Active - Recruiting

  • Little Eyes Pediatric Eye Care

    Carmel, Indiana 46032
    United States

    Active - Recruiting

  • All Eyes on Rockville

    Rockville, Maryland 20852
    United States

    Active - Recruiting

  • Wellesley Vision Group at Optical Design

    Wellesley, Massachusetts 02482
    United States

    Active - Recruiting

  • Missouri Eye Consultants - California

    California, Missouri 65018
    United States

    Active - Recruiting

  • Center for Vision and Learning

    Des Peres, Missouri 63131
    United States

    Active - Recruiting

  • Advocare Pediatric Eye Physicians

    Morristown, New Jersey 07960
    United States

    Active - Recruiting

  • Bronx Eye Associates

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Queens Optometric Care, Plc

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Clarity Vision

    Apex, North Carolina 27502
    United States

    Active - Recruiting

  • Cary Family Eye Care

    Cary, North Carolina 27519
    United States

    Active - Recruiting

  • Chagrin Valley Optometrists, Inc.

    Chagrin Falls, Ohio 44023
    United States

    Active - Recruiting

  • Pickerington Eye Care

    Pickerington, Ohio 43147
    United States

    Active - Recruiting

  • Nittany Eye Associates, LLC

    State College, Pennsylvania 16801
    United States

    Active - Recruiting

  • Texas State Optical

    Beaumont, Texas 77706
    United States

    Active - Recruiting

  • Bellaire Family Eye Care

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Drs. McIntyre, Garza, Avila and Jurica, Optometrists

    Corpus Christi, Texas 78411
    United States

    Active - Recruiting

  • Clarkson EyeCare KIDS

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • Lone Star Vision Center

    Plano, Texas 75024
    United States

    Active - Recruiting

  • Stone Oak Vision Source

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Child & Family Eye Care Center

    Pleasant Grove, Utah 84062
    United States

    Active - Recruiting

  • Broadway Eye Clinic

    Salt Lake City, Utah 84111
    United States

    Active - Recruiting

  • Invision Eye Health

    Sandy, Utah 84070
    United States

    Active - Recruiting

  • Colonial Eye Care

    Williamsburg, Virginia 23185
    United States

    Active - Recruiting

  • Redmond Eye Clinic

    Redmond, Washington 98052
    United States

    Active - Recruiting

  • Spectrum Optical, PLLC

    Morgantown, West Virginia 26505
    United States

    Active - Recruiting

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