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Safety of MiSight 1 Day contact lenses for myopia in children

MiSight 1 Day Safety Post-Approval Study

Not applicable Interventional CooperVision International Limited (CVIL) · NCT05285527

This study is testing if MiSight 1 Day contact lenses are safe for children aged 8 to 12 who need help with their vision.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2400 (estimated)
Ages8 Years to 12 Years
SexAll
SponsorCooperVision International Limited (CVIL) Industry-sponsored
Locations50 sites (Gilbert, Arizona and 49 other locations)
Trial IDNCT05285527 on ClinicalTrials.gov

What this trial studies

This post-approval study aims to confirm the safety of MiSight 1 Day soft contact lenses among children aged 8 to 12 years in the United States. Participants who meet specific inclusion criteria will wear the lenses daily for approximately 10 hours over a six-day week. The study will also utilize safety data from a previous effectiveness study to enhance the findings. The goal is to ensure that these lenses are safe for the intended pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children aged 8 to 12 years with a specific range of myopia and no ocular diseases.

Not a fit: Patients outside the age range or with significant ocular abnormalities may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide reassurance about the safety of MiSight 1 Day lenses for children with myopia.

How similar studies have performed: Previous studies on similar contact lenses have shown promising safety and effectiveness outcomes, suggesting a favorable context for this study.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Gilbert, Arizona and 49 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 → Find more trials like this →
Conditions Myopia
Last reviewed 2026-06-10 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.