MiSight 1 Day Safety Post-Approval Study

NCT05285527 | Recruiting DMC FDA Device

• 1 other identifier: PAS002
• Study Type: interventional
• Target: 2,400
• Locations: 2 countries
• Sites: 50

Brief 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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (1)

• Incidence of Microbial Keratitis (MK)

  Incidence of Microbial Keratitis (MK) ≥ 1 mm

  3 years

Secondary Outcomes (3)

• Incidence of peripheral infiltrative keratitis/non-infectious ulcers

  3 years

• Incidence of non-infectious infiltrative keratitis

  3 years

• Incidence of loss of best-corrected visual acuity

  3 years

Study Arms (1)

MiSight 1 Day

EXPERIMENTAL

MiSight 1 Day

Device: MiSight 1 Day

Interventions

MiSight 1 Day DEVICE

Subjects will wear MiSight 1 day lenses for three years.

MiSight 1 Day

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Be between 8 and 12 years of age inclusive at the time of enrollment.
• Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.50 D and -7.00 D inclusive (at the corneal plane).
• Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally
• Free of ocular disease or abnormalities (including any corneal scar)
• 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.
• Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data.
• Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week.
• Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses.

You may not qualify if:

• Acute and subacute inflammation or infection of the anterior chamber of the eye.
• Any eye disease, injury, or abnormality that affects the cornea, conjunctiva, or eyelids.
• Severe insufficiency of lacrimal secretion (dry eyes).
• Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic.
• Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.
• Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions.
• Any active corneal infection (bacterial, fungal, or viral).
• If eyes are red or irritated.
• The patient is unable to follow lens handling and wear regimen or unable to obtain assistance to do so.
• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (50)

Experts on Sight LLC.

Gilbert, Arizona, 85297, United States

RECRUITING

Centerton Family Eyecare

Centerton, Arkansas, 72719, United States

RECRUITING

University of California, Berkeley University Eye Center

Berkeley, California, 94720, United States

RECRUITING

Golden Vision Cupertino Optometry

Cupertino, California, 95014, United States

RECRUITING

Boghossian Vision

Danville, California, 94506, United States

RECRUITING

Iron Horse Optometric Group

Dublin, California, 94568, United States

RECRUITING

Capitol Eye Care Center Optometry

Fremont, California, 94536, United States

RECRUITING

Irvine Eye Physicians and Surgeons Inc

Irvine, California, 92618, United States

RECRUITING

Elsa Pao OD, Inc

Oakland, California, 94607, United States

RECRUITING

Perfect Pair Optometry

San Jose, California, 95118, United States

RECRUITING

Almaden Family Optometric Center

San Jose, California, 95120, United States

RECRUITING

Children's Eye Physicians

Centennial, Colorado, 80112, United States

RECRUITING

Eye Physicians & Surgeons, PC

Milford, Connecticut, 06460, United States

RECRUITING

Planet Vision Eyecare

Lake Worth, Florida, 33467, United States

RECRUITING

Marino Eye Care

Miami, Florida, 33156, United States

RECRUITING

Vision Source Oviedo, INC

Oviedo, Florida, 32765, United States

RECRUITING

Dau Family Eye Care

Saint Johns, Florida, 32259, United States

RECRUITING

Gulf Coast Eye Center

Sarasota, Florida, 34239, United States

RECRUITING

Weston Contact Lens Institute LLC

Weston, Florida, 33331, United States

RECRUITING

Lurie Childrens

Chicago, Illinois, 60611, United States

RECRUITING

Lyons Family Eye Care P.C.

Chicago, Illinois, 60657, United States

RECRUITING

Darien Eye Specialists

Darien, Illinois, 60561, United States

RECRUITING

Carillon Vision Care

Glenview, Illinois, 60025, United States

RECRUITING

Little Eyes Pediatric Eye Care

Carmel, Indiana, 46032, United States

RECRUITING

All Eyes on Rockville

Rockville, Maryland, 20852, United States

RECRUITING

Wellesley Vision Group at Optical Design

Wellesley, Massachusetts, 02482, United States

RECRUITING

Missouri Eye Consultants - California

California, Missouri, 65018, United States

RECRUITING

Center for Vision and Learning

Des Peres, Missouri, 63131, United States

RECRUITING

Advocare Pediatric Eye Physicians

Morristown, New Jersey, 07960, United States

RECRUITING

Bronx Eye Associates

The Bronx, New York, 10467, United States

RECRUITING

Clarity Vision

Apex, North Carolina, 27502, United States

RECRUITING

Cary Family Eye Care

Cary, North Carolina, 27519, United States

RECRUITING

Chagrin Valley Optometrists, Inc.

Chagrin Falls, Ohio, 44023, United States

RECRUITING

Pickerington Eye Care

Pickerington, Ohio, 43147, United States

RECRUITING

Nittany Eye Associates, LLC

State College, Pennsylvania, 16801, United States

RECRUITING

Texas State Optical

Beaumont, Texas, 77706, United States

RECRUITING

Bellaire Family Eye Care

Bellaire, Texas, 77401, United States

RECRUITING

Drs. McIntyre, Garza, Avila and Jurica, Optometrists

Corpus Christi, Texas, 78411, United States

RECRUITING

Clarkson EyeCare KIDS

Frisco, Texas, 75034, United States

RECRUITING

Lone Star Vision Center

Plano, Texas, 75024, United States

RECRUITING

Stone Oak Vision Source

San Antonio, Texas, 78258, United States

RECRUITING

Child & Family Eye Care Center

Pleasant Grove, Utah, 84062, United States

RECRUITING

Broadway Eye Clinic

Salt Lake City, Utah, 84111, United States

RECRUITING

Invision Eye Health

Sandy City, Utah, 84070, United States

RECRUITING

Colonial Eye Care

Williamsburg, Virginia, 23185, United States

RECRUITING

Redmond Eye Clinic

Redmond, Washington, 98052, United States

RECRUITING

Spectrum Optical, PLLC

Morgantown, West Virginia, 26505, United States

RECRUITING

Dr. Kit Guan & Associates

Markham, Ontario, L3R3P9, Canada

RECRUITING

Abbey Eye Care

Oakville, Ontario, L6M5A9, Canada

RECRUITING

Optometry Professional Corporation

Toronto, Ontario, M2N 3A1, Canada

RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• William Gleason, OD

  Foresight Regulatory Strategies

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Richdale, OD, PhD

CONTACT

917-755-4548; MiSight.SafetyPAS@coopervision.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2022
• First Posted: March 17, 2022
• Study Start: August 15, 2022
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08

Locations

US (47); CA (3)