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

Exclusion Criteria22

• 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.