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Contact lenses that could slow nearsightedness in kids

NCT ID NCT05285553

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests whether MiSight 1 Day contact lenses can slow the progression of myopia (nearsightedness) in children aged 8 to 12. Participants wear either MiSight 1 Day or standard Proclear 1 day lenses for three years, then all switch to Proclear for one year to see if the effect lasts. The goal is to confirm the lenses work in real-world clinics and reduce the need for stronger prescriptions.

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 lens
What this could lead to
If successful, this could confirm that MiSight 1 Day lenses effectively slow myopia progression in children, offering a non-surgical way to manage nearsightedness.
What could go wrong
This is a post-approval study, so the lens is already on the market. However, results may vary, and some children may still experience myopia progression. Visual symptoms or discomfort could occur.

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 900 people

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

Started

Jun 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. Informed Consent and Assent have been completed 2. Be between 8 and 12 years of age inclusive at the time of enrollment. 3. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye 4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye. 5. Anisometropia: ≤ 1.50D SERE. 6. Astigmatism: ≤ 0.75 D 7. Free of ocular disease or abnormalities (including any corneal scar) 8. Currently have good general health. 9. Agree to accept the lens as assigned by the randomization. 10. Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol. 11. Ability to comply with study procedures, including high and low (sub-study only) contrast high and low (sub-study only) lighting visual acuity, axial length, and cycloplegic auto-refraction measurements taken for both eyes. 12. Able to maintain the visit schedule. 13. Willingness to participate in the trial for 4 years. 14. Interested in wearing contact lenses for approximately 10 hours per day and 6 days per week. 15. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses. Exclusion Criteria: 1. Current or prior use of any pharmaceuticals or other methods for control of myopia, such as bifocals, progressive addition lenses, orthokeratology, atropine, pirenzepine or any other myopia control treatment. 2. Use of any systemic or topical ocular medications or over-the-counter artificial tears which might interfere with contact lens wear, pupil size, accommodation or refractive state, or require the lenses to be removed during the day. 3. Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses 4. Has any of the following specific contraindications to MiSight 1 Day lenses at Baseline Visit: * 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. 5. Has history of: * Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or other recurrent ocular infections. * Giant papillary conjunctivitis * Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses * A known allergy to fluorescein, benoxinate, proparacaine or tropicamide. * Corneal hypoesthesia (reduced corneal sensitivity) 6. Keratoconus or an irregular cornea. 7. Strabismus or amblyopia. 8. Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.

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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

  • Athens Eye Care

    Athens, Ohio, 45701, United States

  • Brain Vision Institute

    Schaumburg, Illinois, 60194, United States

  • Bright Eyes Family Vision Care

    Tampa, Florida, 33626, United States

  • Carillon Vision Care

    Glenview, Illinois, 60025, United States

  • Chicago College of Optometry

    Downers Grove, Illinois, 60515, United States

  • Clinical Optics Research Lab at IU School of Optometry

    Bloomington, Indiana, 47406, United States

  • Coan Eye Care and Optical Boutique

    Ocoee, Florida, 34761, United States

  • Cornea and Contact Lens Institute

    Edina, Minnesota, 55436, United States

  • Eye Care Professionals

    Powell, Ohio, 43065, United States

  • Factoria Eye Clinic

    Bellevue, Washington, 98006, United States

  • Illinois College of Optometry

    Chicago, Illinois, 60616, United States

  • Kannarr Eye Care

    Pittsburg, Kansas, 66762, United States

  • Lone Star Vision

    Plano, Texas, 75024, United States

  • Marshall B. Ketchum University Southern California College of Optometry

    Fullerton, California, 92831, United States

  • Miamisburg Vision Care

    Miamisburg, Ohio, 45342, United States

  • New England College of Optometry

    Boston, Massachusetts, 02115, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Paje Optometric

    Santa Ana, California, 92704, United States

  • ProCare Vision Center, Inc.

    Granville, Ohio, 43023, United States

  • SoLo Eye Care & Eyewear Gallery

    Chicago, Illinois, 60608, United States

  • Southern College of Optometry

    Memphis, Tennessee, 38104, United States

  • Texas State Optical

    Beaumont, Texas, 77706, United States

  • University of Alabama School of Optometry

    Birmingham, Alabama, 35233, United States

  • University of Houston College of Optometry

    Houston, Texas, 77204, United States

  • Utah Eye Centers

    Ogden, Utah, 84403, United States

  • Virginia Pediatric Eye Care

    Chesapeake, Virginia, 23320, United States

  • Vision One Eyecare

    Katy, Texas, 77450, United States

  • Vision Solutions Optometry Inc

    La Mesa, California, 91942, United States

  • Vision Source EyeCare

    Kansas City, Missouri, 64111, United States

  • West Broward Eyecare Associates

    Tamarac, Florida, 33321, United States

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