Evaluating ACUVUE® Abiliti™ 1-Day Soft Therapeutic Lenses for Myopia Management

Inclusion Criteria:

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

1. The subject's parents or legal guardians must read, understand, and sign theSTATEMENT OF INFORMED CONSENT (Parental Permission Form and Authorization to Use andDisclose Medical Information). The subject must read (or be read to) and sign theCHILDREN'S ASSENT (Information and Assent Form) and receive a fully executed copy ofthe form.

2. Appear able and willing to adhere to the instructions set forth in this clinicalprotocol.

3. Between 7 and 12 (inclusive) years of age at the time of screening.

4. Be of Chinese ethnicity, which is defined as with both biological parents being ofChinese ethnicity).

5. Have normal eyes (i.e., no ocular medications or infections of any type).

6. Have non-vertex corrected subjective spherical distance refraction in the range of -0.75 D to -4.50 D (inclusive) in each eye.

7. Have refractive cylinder in the range of 0.00 D to 1.00 D (inclusive) in each eyewith any degree of axis, by subjective sphero-cylindrical refraction.

8. Have sphero-cylindrical best-corrected visual acuity of 0.04 logMAR (4.95 in Chinastandard 5-point logMAR scoring convention) or better in each eye, and thedifference of sphero-cylindrical best-corrected visual acuity between the two eyesis less than 0.20 logMAR (0.2 points difference in China standard 5-point logMARscoring convention).

9. Spherical equivalent power of cycloplegic objective spherocylindrical refraction (byauto refraction) between -0.75 D and -4.50 D (inclusive) and cylinder power of 1.00D or less in each eye (based on the average of 5 repeated sphero-cylindricalrefraction measures and rounded to the nearest 1/8 D).

10. The difference in spherical equivalent power between the two eyes be less than orequal to 1.50 D (based on the average of 5 repeated sphero-cylindrical refractionmeasures and rounded to the nearest 1/8 D).

Exclusion Criteria:

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

1. Have any systemic disease (e.g., Sjögren's Syndrome), allergies, infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., HIV),autoimmune disease (e.g., rheumatoid arthritis), any underlying medical conditionthat makes subjects at risk of severe COVID complications, or other diseases, byparent of legal guardian's self-report, which are known to interfere with contactlens wear and/or participation in the study.

2. Use of systemic medications (e.g., chronic steroid use) that are known to interferewith contact lens wear and/or participation in the study. See Section 9 foradditional details regarding excluded systemic medications.

3. Any current use of ocular medication (occasional use of re-wetting drops isallowed).

4. Chronic or seasonal use of ophthalmic topical medication that are specified asdisallowed medications in Section 9 of the protocol.

5. Chronic use of any topical antimuscarinic agents for any reason.

6. Recent temporary use (within 21 days from enrollment) of topical agents withanti-muscarinic properties. This includes but is not limited to scopolamine,pirenzepine, tropicamide, cyclopentolate and homatropine.

7. Any known hypersensitivity or allergic reaction to cyclopentolate, topicalanesthetics or Sponsor approved rewetting drop solutions available in local markets.

8. Any previous or planned (during the course of the study) ocular surgery (e.g.,radial keratotomy, PRK, LASIK, etc.).

9. Participation in any contact lens or lens care product clinical trial within 30 daysprior to study enrollment.

10. History of myopia control treatment or participation in any prior myopia controlclinical study in the test group with an optical intervention for more than 2 weeks.This includes but is not limited to orthokeratology treatment or use of otherophthalmic devices (e.g., bifocal, multifocal or other novel contact or spectacleslenses).

11. History of myopia control treatment or participation in any prior myopia controlclinical study in the test group with any pharmacological intervention (e.g.,atropine or pirenzepine).

12. Current or recent (within 60 days from enrollment) wear of orthokeratology lenses,bifocal, multifocal contact lenses or bifocal, multifocal spectacles.

13. Be current or recent (within 30 days from enrollment) rigid lens wearers.

14. Be immediate family member of an employee of clinical site (e.g., Investigator,Coordinator, Technician).

15. Any ocular allergies, infections or other ocular abnormalities that are known tointerfere with contact lens wear and/or participation in the study. This mayinclude, but not be limited to entropion, ectropion, extrusions, chalazia, recurrentstyes, ocular hypertension, glaucoma, history of recurrent corneal erosions,aphakia, uveitis, severe keratoconjunctivitis sicca, keratoconus, keratoconussuspect, and pellucid marginal degeneration.

16. Grade 3 or greater palpebral conjunctival observations or any other Grade 2 orgreater slit lamp findings (e.g., edema, corneal neovascularization, cornealstaining, conjunctival injection) on the ISO 11980 classification scale.

17. Any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocularabnormality that may contraindicate contact lens wear or subjects' participation inthe study.

18. Any central corneal scar.

19. Any corneal distortion resulting from ocular diseases or previous hard or rigid gaspermeable contact lens wear.

20. Binocular vision abnormality, intermittent strabismus or strabismus.

21. Anterior chamber angle is Grade 2 or narrower in either eye.

22. Intraocular pressure (IOP) is higher than 21 mmHg in either eye

23. Pupil diameter under bright illumination is less than 2 mm in either eye.

24. Pupil pathology.

25. Fundus pathology.

26. Any other issue that would impair the ability of the participant to receive ortolerate the planned treatment at the investigational site, to understand informedconsent or any condition for which, in the opinion of the investigator,participation would not be in the best interest of the participant (e.g., compromisethe well-being) or that could prevent, limit, or confound the protocol-specifiedassessments.