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Contact lens safety check for kids with myopia

NCT ID NCT05285527

Disease control Sponsor: CooperVision, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study looks at the safety of MiSight 1 Day contact lenses in children aged 8 to 12 with nearsightedness (myopia). Participants wear the lenses daily for three years, and researchers track eye infections and other problems. The goal is to confirm that these lenses are safe for long-term use in young people.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MiSight 1 Day contact lenses
What this could lead to
If successful, this study could confirm that daily disposable contact lenses are a safe option for managing myopia in children.
What could go wrong
This is a safety confirmation study, not a test of effectiveness. Rare but serious risks like microbial keratitis may still occur, and results may not apply to all lens wearers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 2,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

8 to 12 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

myopia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myopia

Contacts and locations

Locations

  • Abbey Eye Care

    Oakville, Ontario, L6M5A9, Canada

  • Advocare Pediatric Eye Physicians

    Morristown, New Jersey, 07960, United States

  • All Eyes on Rockville

    Rockville, Maryland, 20852, United States

  • Almaden Family Optometric Center

    San Jose, California, 95120, United States

  • Bellaire Family Eye Care

    Bellaire, Texas, 77401, United States

  • Boghossian Vision

    Danville, California, 94506, United States

  • Broadway Eye Clinic

    Salt Lake City, Utah, 84111, United States

  • Bronx Eye Associates

    The Bronx, New York, 10467, United States

  • Capitol Eye Care Center Optometry

    Fremont, California, 94536, United States

  • Carillon Vision Care

    Glenview, Illinois, 60025, United States

  • Cary Family Eye Care

    Cary, North Carolina, 27519, United States

  • Center for Vision and Learning

    Des Peres, Missouri, 63131, United States

  • Centerton Family Eyecare

    Centerton, Arkansas, 72719, United States

  • Chagrin Valley Optometrists, Inc.

    Chagrin Falls, Ohio, 44023, United States

  • Child & Family Eye Care Center

    Pleasant Grove, Utah, 84062, United States

  • Children's Eye Physicians

    Centennial, Colorado, 80112, United States

  • Clarity Vision

    Apex, North Carolina, 27502, United States

  • Clarkson EyeCare KIDS

    Frisco, Texas, 75034, United States

  • Colonial Eye Care

    Williamsburg, Virginia, 23185, United States

  • Darien Eye Specialists

    Darien, Illinois, 60561, United States

  • Dau Family Eye Care

    St. Johns, Florida, 32259, United States

  • Dr. Kit Guan & Associates

    Markham, Ontario, L3R3P9, Canada

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

    Corpus Christi, Texas, 78411, United States

  • Elsa Pao OD, Inc

    Oakland, California, 94607, United States

  • Experts on Sight LLC.

    Gilbert, Arizona, 85297, United States

  • Eye Physicians & Surgeons, PC

    Milford, Connecticut, 06460, United States

  • Golden Vision Cupertino Optometry

    Cupertino, California, 95014, United States

  • Gulf Coast Eye Center

    Sarasota, Florida, 34239, United States

  • Invision Eye Health

    Sandy City, Utah, 84070, United States

  • Iron Horse Optometric Group

    Dublin, California, 94568, United States

  • Irvine Eye Physicians and Surgeons Inc

    Irvine, California, 92618, United States

  • Little Eyes Pediatric Eye Care

    Carmel, Indiana, 46032, United States

  • Lone Star Vision Center

    Plano, Texas, 75024, United States

  • Lurie Childrens

    Chicago, Illinois, 60611, United States

  • Lyons Family Eye Care P.C.

    Chicago, Illinois, 60657, United States

  • Marino Eye Care

    Miami, Florida, 33156, United States

  • Missouri Eye Consultants - California

    California, Missouri, 65018, United States

  • Nittany Eye Associates, LLC

    State College, Pennsylvania, 16801, United States

  • Optometry Professional Corporation

    Toronto, Ontario, M2N 3A1, Canada

  • Perfect Pair Optometry

    San Jose, California, 95118, United States

  • Pickerington Eye Care

    Pickerington, Ohio, 43147, United States

  • Planet Vision Eyecare

    Lake Worth, Florida, 33467, United States

  • Redmond Eye Clinic

    Redmond, Washington, 98052, United States

  • Spectrum Optical, PLLC

    Morgantown, West Virginia, 26505, United States

  • Stone Oak Vision Source

    San Antonio, Texas, 78258, United States

  • Texas State Optical

    Beaumont, Texas, 77706, United States

  • University of California, Berkeley University Eye Center

    Berkeley, California, 94720, United States

  • Vision Source Oviedo, INC

    Oviedo, Florida, 32765, United States

  • Wellesley Vision Group at Optical Design

    Wellesley, Massachusetts, 02482, United States

  • Weston Contact Lens Institute LLC

    Weston, Florida, 33331, United States

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