MiSight 1 Day Safety Post-Approval Study

Study Overview
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Brief Summary
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The purpose of this post-approval study is to confirm the safety of daily disposable soft contact lens wear among the intended patient population for the MiSight 1 Day lens in the US.

Detailed Description
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This prospective post-approval study of safety in a US study population is to confirm the safety of MiSight 1 day lenses. Consecutive subjects receiving the MiSight 1 Day lens, who meet the inclusion criteria, will be prospectively offered to participate in the study. Additionally, safety data from the MiSight 1 Day Post-Approval Study for Effectiveness and Visual Symptoms (PAS001) will be used to supplement this safety study.

Official Title
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MiSight 1 Day Safety Post-Approval Study

Conditions
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Myopia

Intervention / Treatment
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* Device: MiSight 1 Day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Best-corrected visual acuity by manifest refraction of at least 20/25 bilaterally Anisometropia: ≤ 1.50D SERE. Astigmatism: ≤ -0.75 D Free of ocular disease or abnormalities (including any corneal scar) 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. Parent/Guardian must sign the Release of Medical Records associated with the outcomes of interest identified from claims data. 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MiSight 1 Day<br>MiSight 1 Day | Device: MiSight 1 Day<br>* Subjects will wear MiSight 1 day lenses for three years.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Microbial Keratitis (MK) | Incidence of Microbial Keratitis (MK) ≥ 1 mm | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of peripheral infiltrative keratitis/non-infectious ulcers | Incidence of peripheral infiltrative keratitis/non-infectious ulcers ≤ 1 mm | 3 years | 
| Incidence of non-infectious infiltrative keratitis | Incidence of non-infectious infiltrative keratitis ≤ 1 mm | 3 years | 
| Incidence of loss of best-corrected visual acuity | Incidence of loss of best-corrected visual acuity ≥ 2 lines for any adjudicated adverse event. | 3 years |