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

Inclusion Criteria:

1. Informed Consent and Assent have been completed

2. Be between 8 and 12 years of age inclusive at the time of enrollment.

3. Manifest Refraction - Spherical Equivalent Refractive Error (SERE) at baselinebetween -0.75 D and -4.00 D inclusive (at the corneal plane) in each eye

4. Best-corrected visual acuity by manifest refraction of +0.10 logMAR (20/25 Snellenequivalent) or better in each eye.

5. Anisometropia: ≤ 1.50D SERE.

6. Astigmatism: ≤ 0.75 D

7. Free of ocular disease or abnormalities (including any corneal scar)

8. Currently have good general health.

9. Agree to accept the lens as assigned by the randomization.

10. Be capable of comprehending the nature of the study and be willing and able toadhere to the instructions set forth in this protocol.

11. 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, andcycloplegic auto-refraction measurements taken for both eyes.

12. Able to maintain the visit schedule.

13. Willingness to participate in the trial for 4 years.

14. Interested in wearing contact lenses for approximately 10 hours per day and 6 daysper week.

15. Possesses, or obtains prior to dispensing, wearable and visually functional (20/40or better) eyeglasses.

Exclusion Criteria:

1. 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.

2. Use of any systemic or topical ocular medications or over-the-counter artificialtears which might interfere with contact lens wear, pupil size, accommodation orrefractive state, or require the lenses to be removed during the day.

3. Previously worn or currently wears rigid gas permeable contact lenses, includingorthokeratology lenses

4. Has any of the following specific contraindications to MiSight 1 Day lenses atBaseline Visit:

• Acute and subacute inflammation or infection of the anterior chamber of theeye.

• 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 wearingcontact lenses.

• Allergic reactions of ocular surfaces or adnexa that may be induced orexaggerated 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 toobtain assistance to do so.

5. Has history of:

• Corneal ulcer, corneal infiltrates, ocular viral or fungal infections or otherrecurrent ocular infections.

• Giant papillary conjunctivitis

• Allergic reactions of ocular surfaces or adnexa that may be induced orexaggerated by wearing contact lenses

• A known allergy to fluorescein, benoxinate, proparacaine or tropicamide.

• Corneal hypoesthesia (reduced corneal sensitivity)

6. Keratoconus or an irregular cornea.

7. Strabismus or amblyopia.

8. Any systemic disease that may affect the eye or be exaggerated by wearing contactlenses.