Efficacy in Controlling Myopia in Young Children Using a Novel Spectacle Lens

Inclusion Criteria:

1. Children 6 - 8 years of age (inclusive) at time of informed consent/assent;

2. Spherical equivalent refractive error between -0.75 and -4.50 D inclusive (bymanifest refraction) in each eye;

3. Astigmatism if present, less than or equal to -1.25 DC (by manifest refraction) ineach eye;

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

5. The difference in spherical equivalent power between the two eyes (anisometropiabased on manifest refraction) must be less than or equal to 1.50 D;

6. Agree to wear the assigned spectacles constantly except for sleeping, swimming, orother activities in which spectacle wear would be dangerous or otherwise notpossible (minimum of 10 hours per day);

7. Ability to comply with study procedures, including high and low contrast visualacuity, axial length, and cycloplegic autorefraction measurements taken for botheyes at the baseline visit;

8. Willingness to participate in the trial for 24 months without contact lens wear;

9. The subject's parent(s) or legal guardian(s) must read, understand and sign theStatement of Informed Consent and receive a fully executed copy of the form.

Exclusion Criteria:

1. Subject has previously or currently wears contact lenses (greater than 1-monthusage);

2. Current or prior use of bifocals, progressive addition spectacle lenses

3. Current or prior use of any myopia control treatment (e.g., atropine, multifocalcontact lenses, orthokeratology);

4. Amblyopia in either eye;

5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction;

6. Any ocular or systemic conditions that could influence refractive development orstatus [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfansyndrome or other connective tissue disorder, Down's syndrome, family history ofpoor night vision (to prevent against enrolling subjects with congenital stationarynight blindness)];

7. Known allergy to proparacaine, tetracaine, or tropicamide;

8. Participation in any investigational clinical study within 30 days of the Baselinevisit;

9. Subject's sibling or other household member is already enrolled in this trial.