MiSight 1 Day Safety Post-Approval Study

NCT ID: NCT05285527

Last Updated: 2025-08-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2027-05-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myopia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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MiSight 1 Day

MiSight 1 Day

Group Type EXPERIMENTAL

MiSight 1 Day

Intervention Type DEVICE

Subjects will wear MiSight 1 day lenses for three years.

Interventions

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MiSight 1 Day

Subjects will wear MiSight 1 day lenses for three years.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CooperVision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Gleason, OD

Role: PRINCIPAL_INVESTIGATOR

Foresight Regulatory Strategies

Locations

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Experts on Sight LLC.

Gilbert, Arizona, United States

Site Status RECRUITING

Centerton Family Eyecare

Centerton, Arkansas, United States

Site Status RECRUITING

University of California, Berkeley University Eye Center

Berkeley, California, United States

Site Status RECRUITING

Golden Vision Cupertino Optometry

Cupertino, California, United States

Site Status RECRUITING

Boghossian Vision

Danville, California, United States

Site Status RECRUITING

Iron Horse Optometric Group

Dublin, California, United States

Site Status RECRUITING

Capitol Eye Care Center Optometry

Fremont, California, United States

Site Status RECRUITING

Irvine Eye Physicians and Surgeons Inc

Irvine, California, United States

Site Status RECRUITING

Elsa Pao OD, Inc

Oakland, California, United States

Site Status RECRUITING

Perfect Pair Optometry

San Jose, California, United States

Site Status RECRUITING

Almaden Family Optometric Center

San Jose, California, United States

Site Status RECRUITING

Children's Eye Physicians

Centennial, Colorado, United States

Site Status RECRUITING

Eye Physicians & Surgeons, PC

Milford, Connecticut, United States

Site Status RECRUITING

Planet Vision Eyecare

Lake Worth, Florida, United States

Site Status RECRUITING

Marino Eye Care

Miami, Florida, United States

Site Status RECRUITING

Vision Source Oviedo, INC

Oviedo, Florida, United States

Site Status RECRUITING

Dau Family Eye Care

Saint Johns, Florida, United States

Site Status RECRUITING

Gulf Coast Eye Center

Sarasota, Florida, United States

Site Status RECRUITING

Weston Contact Lens Institute LLC

Weston, Florida, United States

Site Status RECRUITING

Lurie Childrens

Chicago, Illinois, United States

Site Status RECRUITING

Lyons Family Eye Care P.C.

Chicago, Illinois, United States

Site Status RECRUITING

Darien Eye Specialists

Darien, Illinois, United States

Site Status RECRUITING

Carillon Vision Care

Glenview, Illinois, United States

Site Status RECRUITING

Little Eyes Pediatric Eye Care

Carmel, Indiana, United States

Site Status RECRUITING

All Eyes on Rockville

Rockville, Maryland, United States

Site Status RECRUITING

Wellesley Vision Group at Optical Design

Wellesley, Massachusetts, United States

Site Status RECRUITING

Missouri Eye Consultants - California

California, Missouri, United States

Site Status RECRUITING

Center for Vision and Learning

Des Peres, Missouri, United States

Site Status RECRUITING

Advocare Pediatric Eye Physicians

Morristown, New Jersey, United States

Site Status RECRUITING

Bronx Eye Associates

The Bronx, New York, United States

Site Status RECRUITING

Clarity Vision

Apex, North Carolina, United States

Site Status RECRUITING

Cary Family Eye Care

Cary, North Carolina, United States

Site Status RECRUITING

Chagrin Valley Optometrists, Inc.

Chagrin Falls, Ohio, United States

Site Status RECRUITING

Pickerington Eye Care

Pickerington, Ohio, United States

Site Status RECRUITING

Nittany Eye Associates, LLC

State College, Pennsylvania, United States

Site Status RECRUITING

Texas State Optical

Beaumont, Texas, United States

Site Status RECRUITING

Bellaire Family Eye Care

Bellaire, Texas, United States

Site Status RECRUITING

Drs. McIntyre, Garza, Avila and Jurica, Optometrists

Corpus Christi, Texas, United States

Site Status RECRUITING

Clarkson EyeCare KIDS

Frisco, Texas, United States

Site Status RECRUITING

Lone Star Vision Center

Plano, Texas, United States

Site Status RECRUITING

Stone Oak Vision Source

San Antonio, Texas, United States

Site Status RECRUITING

Child & Family Eye Care Center

Pleasant Grove, Utah, United States

Site Status RECRUITING

Broadway Eye Clinic

Salt Lake City, Utah, United States

Site Status RECRUITING

Invision Eye Health

Sandy City, Utah, United States

Site Status RECRUITING

Colonial Eye Care

Williamsburg, Virginia, United States

Site Status RECRUITING

Redmond Eye Clinic

Redmond, Washington, United States

Site Status RECRUITING

Spectrum Optical, PLLC

Morgantown, West Virginia, United States

Site Status RECRUITING

Dr. Kit Guan & Associates

Markham, Ontario, Canada

Site Status RECRUITING

Abbey Eye Care

Oakville, Ontario, Canada

Site Status RECRUITING

Optometry Professional Corporation

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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United States Canada

Central Contacts

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Kathryn Richdale, OD, PhD

Role: CONTACT

917-755-4548

Facility Contacts

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Jashpal Rajasansi, O.D.

Role: primary

Megan Petty, OD

Role: primary

Yue (Maria) Liu, O.D.

Role: primary

Pearl Shih, O.D.

Role: primary

Margaret Burton, OD

Role: primary

Sara Chiu, OD

Role: primary

Stella Levin, OD

Role: primary

David W Chia, MD

Role: primary

Elsa Pao, OD

Role: primary

Brian H Kitajima, OD

Role: primary

Pei-Chen (Jennifer) Hsieh, O.D.

Role: primary

Rebecca Phung, OD

Role: primary

Darron Bacal, O.D.

Role: primary

Hetel Bhakta, OD

Role: primary

Vanessa C Marino, OD

Role: primary

David Fisher, O.D.

Role: primary

Jordan Dau, OD

Role: primary

Steven Bovio, OD

Role: primary

Elise Kramer, OD

Role: primary

Noreen Shaikh, O.D.

Role: primary

Stephanie Lyons, OD

Role: primary

Shinu Varghese, OD

Role: primary

Andrew Neukirch, OD

Role: primary

Katherine Schuetz, O.D.

Role: primary

Hannah Neubauer, OD

Role: primary

Anhthy T. Prendeville, O.D.

Role: primary

Jacqueline Bryd, O.D.

Role: primary

Cheryl Davidson, O.D.

Role: primary

Lucy Chen, MD

Role: primary

Eleonora Orloff, O.D.

Role: primary

David J Holler, OD

Role: primary

Dwight Barnes, OD

Role: primary

Jenna Lewis, OD

Role: primary

Eriq Hall, OD

Role: primary

Michael Cymbor, OD

Role: primary

Samir N Patel, OD

Role: primary

Ashley W Tucker, OD

Role: primary

Amy Luu Mai, O.D.

Role: primary

Carlee Young, O.D.

Role: primary

Paola Diaz, OD

Role: primary

Mann Chandler, OD

Role: primary

Jeremy Gardner, O.D.

Role: primary

Karri Buresh, OD

Role: primary

Christopher Snow, O.D.

Role: primary

Kelsey Guth, OD

Role: primary

Jeffrey Binstock, DVM, OD

Role: primary

Jordan Hamric, O.D.

Role: primary

Kit Guan, OD

Role: primary

905-604-4122

Tina Goodhew, OD

Role: primary

905-847-3937

Fiona Soong, Dr.

Role: primary

Other Identifiers

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PAS002

Identifier Type: -

Identifier Source: org_study_id

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