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

Study Overview
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Brief Summary
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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.

Detailed Description
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This study is a multicenter, parallel-group, controlled, double-masked (subject and investigator), randomized clinical trial with a total duration of four years. Part 1 of this study will study the effectiveness of MiSight 1 Day in slowing myopia progression over three years in a US population. Subjects in Part 1 will wear MiSight 1 Day lenses or Proclear 1 day lenses. Part 2 will study the stability of the effectiveness result over a one-year post-treatment period. All subjects in Part 2 will wear Proclear 1 day lenses. Subjects and investigators will remain masked from Part 1.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: MiSight 1 Day
* Device: Proclear 1 day


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MiSight 1 day<br>MiSight 1 day | Device: MiSight 1 Day<br>* Part 1 of the study - subjects will be randomized to wear MiSight 1 Day for three years.<br>|
| Active Comparator: Proclear 1 day<br>Proclear 1 day | Device: Proclear 1 day<br>* Part 1 of the study - subjects will be randomized to wear Proclear 1 day for three years. Part 2 of the study - All the subjects will wear Proclear 1 day lenses for one year.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in cycloplegic SERE change from baseline | Mean difference in cycloplegic SERE change from baseline; measured with cycloplegic auto-refraction in Diopters | 3 years | 
| Mean difference in axial length change from baseline | Mean difference in axial length change from baseline between the MiSight 1 Day group and control lens group, measured in millimeters | 3 years | 
| Mean difference in rate of cycloplegic SERE change - Part 2 study | Mean difference in rate of cycloplegic SERE change between the Part 1 MiSight 1 Day group and the Part 1 control lens group over one-year post-treatment; measured with cycloplegic auto-refraction in Diopters | 1 year | 
| Mean difference in rate of axial length - Part 2 study | Mean difference in rate of axial length change between the Part 1 MiSight 1 Day group and Part 1 control lens group over one-year post-treatment. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with no appreciable myopic progression | Percentage of subjects with no appreciable myopic progression (-0.25D change or less) | 3 years | 
| Visual symptoms and the effects on activities of daily living | Visual symptoms and the effects on activities of daily living are measured using a validated PRO Measure | 3 years |