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RECRUITING

NCT05285527

MiSight 1 Day Safety Post-Approval Study

Sponsor: CooperVision, Inc.

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

8 Years - 12 Years

Study Type

INTERVENTIONAL

Enrollment

2400

Start Date

2022-08-15

Completion Date

2027-05-30

Last Updated

2025-08-14

Healthy Volunteers

Yes

Conditions

Myopia

Interventions

DEVICE

MiSight 1 Day

Subjects will wear MiSight 1 day lenses for three years.

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 baseline between -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 and consent to the use and release of their child's de-identified health care encounter data to be used for purposes of this study. Assent will be obtained from the child in a manner specified by the IRB. 6. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data. 7. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week. 8. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses. 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, or eyelids. 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 contact lenses. 6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by 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 obtain assistance to do so. 10. In addition to the labeling contraindications, children who are under medication that would interfere with contact lens wear, or who are using any pharmaceuticals for control of myopia will not be included in the study.

Locations (50)

Experts on Sight LLC.

Gilbert, Arizona, United States

Centerton Family Eyecare

Centerton, Arkansas, United States

University of California, Berkeley University Eye Center

Berkeley, California, United States

Golden Vision Cupertino Optometry

Cupertino, California, United States

Boghossian Vision

Danville, California, United States

Iron Horse Optometric Group

Dublin, California, United States

Capitol Eye Care Center Optometry

Fremont, California, United States

Irvine Eye Physicians and Surgeons Inc

Irvine, California, United States

Elsa Pao OD, Inc

Oakland, California, United States

Perfect Pair Optometry

San Jose, California, United States

Almaden Family Optometric Center

San Jose, California, United States

Children's Eye Physicians

Centennial, Colorado, United States

Eye Physicians & Surgeons, PC

Milford, Connecticut, United States

Planet Vision Eyecare

Lake Worth, Florida, United States

Marino Eye Care

Miami, Florida, United States

Vision Source Oviedo, INC

Oviedo, Florida, United States

Dau Family Eye Care

Saint Johns, Florida, United States

Gulf Coast Eye Center

Sarasota, Florida, United States

Weston Contact Lens Institute LLC

Weston, Florida, United States

Lurie Childrens

Chicago, Illinois, United States

Lyons Family Eye Care P.C.

Chicago, Illinois, United States

Darien Eye Specialists

Darien, Illinois, United States

Carillon Vision Care

Glenview, Illinois, United States

Little Eyes Pediatric Eye Care

Carmel, Indiana, United States

All Eyes on Rockville

Rockville, Maryland, United States

Wellesley Vision Group at Optical Design

Wellesley, Massachusetts, United States

Missouri Eye Consultants - California

California, Missouri, United States

Center for Vision and Learning

Des Peres, Missouri, United States

Advocare Pediatric Eye Physicians

Morristown, New Jersey, United States

Bronx Eye Associates

The Bronx, New York, United States

Clarity Vision

Apex, North Carolina, United States

Cary Family Eye Care

Cary, North Carolina, United States

Chagrin Valley Optometrists, Inc.

Chagrin Falls, Ohio, United States

Pickerington Eye Care

Pickerington, Ohio, United States

Nittany Eye Associates, LLC

State College, Pennsylvania, United States

Texas State Optical

Beaumont, Texas, United States

Bellaire Family Eye Care

Bellaire, Texas, United States

Drs. McIntyre, Garza, Avila and Jurica, Optometrists

Corpus Christi, Texas, United States

Clarkson EyeCare KIDS

Frisco, Texas, United States

Lone Star Vision Center

Plano, Texas, United States

Stone Oak Vision Source

San Antonio, Texas, United States

Child & Family Eye Care Center

Pleasant Grove, Utah, United States

Broadway Eye Clinic

Salt Lake City, Utah, United States

Invision Eye Health

Sandy City, Utah, United States

Colonial Eye Care

Williamsburg, Virginia, United States

Redmond Eye Clinic

Redmond, Washington, United States

Spectrum Optical, PLLC

Morgantown, West Virginia, United States

Dr. Kit Guan & Associates

Markham, Ontario, Canada

Abbey Eye Care

Oakville, Ontario, Canada

Optometry Professional Corporation

Toronto, Ontario, Canada