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Effectiveness of MiSight 1 Day lenses for myopia management

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

NA · CooperVision International Limited (CVIL) · NCT05285553

This study is testing if MiSight 1 Day contact lenses can help slow down worsening eyesight in children aged 8 to 12 compared to regular contact lenses.

Quick facts

PhaseNA
Study typeInterventional
Enrollment900 (estimated)
Ages8 Years to 12 Years
SexAll
SponsorCooperVision International Limited (CVIL) (industry)
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT05285553 on ClinicalTrials.gov

What this trial studies

This post-approval study aims to confirm the effectiveness of MiSight 1 Day lenses in slowing myopia progression in children aged 8 to 12 years. It is a multicenter, controlled, double-masked, randomized clinical trial that will assess the effectiveness over three years and the stability of results over one year post-treatment. Participants will be assigned to wear either MiSight 1 Day lenses or Proclear 1 Day lenses, with a focus on measuring visual acuity and refractive error. The study will involve multiple locations across the United States.

Who should consider this trial

Good fit: Ideal candidates are children aged 8 to 12 years with specific refractive errors and good general health.

Not a fit: Patients with severe ocular diseases or abnormalities, or those outside the specified age and refractive error range, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective option for managing myopia in children, potentially reducing the progression of the condition.

How similar studies have performed: Other studies have shown promising results with similar approaches to myopia management, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Myopia

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.