MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms

Running, not enrolling · Not applicable

Conditions studied: Myopia

In brief

The purpose of this post-approval study is to confirm the effectiveness of the MiSight 1 Day lens in clinical practices within the US and to assess the stability of the myopia reduction over one-year post-treatment.

Key facts

Study ID

NCT05285553

Run by

CooperVision, Inc.

People needed

900

Starts

2022-06-25

Expected to finish

2030-06-30

Last updated by the study team

2026-07-08

Who can join

Age: 8 and older, up to 12. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Informed Consent and Assent have been completed
• Be between 8 and 12 years of age inclusive at the time of enrollment.
• Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baseline between -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye
• Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellen equivalent) or better in each eye.
• Anisometropia: ≤ 1.50D SERE.
• Astigmatism: ≤ 0.75 D
• Free of ocular disease or abnormalities (including any corneal scar)
• Currently have good general health.
• Agree to accept the lens as assigned by the randomization.
• Be capable of comprehending the nature of the study and be willing and able to adhere to the instructions set forth in this protocol.
• 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.
• Able to maintain the visit schedule.
• Willingness to participate in the trial for 4 years.
• 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…

• 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.
• 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.
• Previously worn or currently wears rigid gas permeable contact lenses, including orthokeratology lenses
• 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.
• 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)
• Keratoconus or an irregular cornea.
• Strabismus or amblyopia.
• Any systemic disease that may affect the eye or be exaggerated by wearing contact lenses.

Where it is running

• University of Alabama School of Optometry — Birmingham, Alabama, United States
• Marshall B. Ketchum University Southern California College of Optometry — Fullerton, California, United States
• Vision Solutions Optometry Inc — La Mesa, California, United States
• Paje Optometric — Santa Ana, California, United States
• Coan Eye Care and Optical Boutique — Ocoee, Florida, United States
• West Broward Eyecare Associates — Tamarac, Florida, United States
• Bright Eyes Family Vision Care — Tampa, Florida, United States
• SoLo Eye Care & Eyewear Gallery — Chicago, Illinois, United States
• Illinois College of Optometry — Chicago, Illinois, United States
• Chicago College of Optometry — Downers Grove, Illinois, United States
• Carillon Vision Care — Glenview, Illinois, United States
• Brain Vision Institute — Schaumburg, Illinois, United States
• Clinical Optics Research Lab at IU School of Optometry — Bloomington, Indiana, United States
• Kannarr Eye Care — Pittsburg, Kansas, United States
• New England College of Optometry — Boston, Massachusetts, United States
• Cornea and Contact Lens Institute — Edina, Minnesota, United States
• Vision Source EyeCare — Kansas City, Missouri, United States
• Athens Eye Care — Athens, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• ProCare Vision Center, Inc. — Granville, Ohio, United States
• Miamisburg Vision Care — Miamisburg, Ohio, United States
• Eye Care Professionals — Powell, Ohio, United States
• Southern College of Optometry — Memphis, Tennessee, United States
• Texas State Optical — Beaumont, Texas, United States
• University of Houston College of Optometry — Houston, Texas, United States

Full record on ClinicalTrials.gov

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