MiSight 1 Day Safety Post-Approval Study

Launched by COOPERVISION, INC. · Mar 9, 2022

Keywords

ClinConnect Summary

The MiSight 1 Day Safety Post-Approval Study is looking to confirm the safety of daily disposable soft contact lenses for children aged 8 to 12 who have myopia, which is a condition where distant objects appear blurry. If your child is between 8 and 12 years old, has a specific level of vision correction need, and is interested in wearing contact lenses for about 10 hours a day, they may be eligible to participate. It’s important that they have glasses they can wear as well.

Participants in this study will wear the MiSight contact lenses while researchers monitor their eye health and comfort. They need to be free from serious eye conditions and infections to ensure safety during the study. The parents or guardians will need to give permission for their child to take part and share some health information. This study is currently recruiting participants, and it’s a great opportunity for children who want to try contact lenses in a safe, supervised environment.

Gender

ALL

Eligibility 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.