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

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.

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.