Study of Safety and Effectiveness of the Boston Orthokeratology Shaping Lens in the Arise Orthokeratology Lens

Inclusion Criteria:

1. Participants should be12 years or older on the date the Informed Consent Form (ICF)is signed and, as subject or parent or legal guardian of a minor subject, havecapacity to read, understand and provide written voluntary informed consent on theIRB approved ICF and provide authorization as appropriate for local privacy. regulations.

2. orthokeratology lens naïve.

3. Spherical refractive error no greater than -5.00D.

4. Astigmatism no greater than 1.50D.

5. Corneal topography sagittal height differential of ≥ 30 microns between the two mainmeridians (flat and steep) at an 8mm chord.

6. Participants should have keratometric readings from 39.00 to 48.00D.

7. Participants should have a clear and undistorted Mire Reflex.

8. Participants should be willing and able to comply with all treatment and follow-upstudy visits and procedures.

9. Participants must be willing to refrain from wearing habitual soft contact lensesduring the study period.

Exclusion Criteria:

1. Subject is considered by the Investigator, to not be a suitable candidate forparticipation or it is not in the best interest of the subject to participate in thestudy.

2. Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 30days or who have worn polymethylmethacrylate (PMMA) lenses within the last threemonths.

3. Prior eyelid, strabismus, intraocular, or refractive surgery.

4. Keratoconus or an irregular cornea.

5. Subjects with any systemic disease currently affecting ocular health or in theInvestigator's opinion may have an effect on ocular health during the course of thestudy.

6. Subjects using any systemic or topical medications that will, in the Investigator'sopinion, affect ocular physiology or lens performance.

7. A known allergy to fluorescein, benoxinate, or proparacaine.

8. A history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer,corneal infiltrates, ocular viral or fungal infections or recurrent ocularinfections.

9. Subjects with an active ocular disease or who are using any ocular medication.

10. Subjects with any Grade 2 or greater finding during the slit lamp examination.Subjects with corneal infiltrates, of ANY GRADE, are NOT eligible. Refer to AppendixB: Methods of Clinical Evaluation.

11. Subjects with any "Present" finding during the slit lamp examination that, in theInvestigator's judgement, interferes with contact lens wear. Refer to Appendix B:Methods of Clinical evaluation.

12. Subjects with any scar or neovascularization within the central 6mm of the cornea.Subjects with minor peripheral corneal scarring (that does not extend into thecentral area), that in the Investigator's judgement, does not interfere with contactlens wear, are eligible for this study.

13. Subjects participating in any drug or device clinical investigation within 2 weeksprior to entry into this study (Screening Visit) and/or planning to do so during theperiod of study participation.

14. Subjects who are amblyopic.

15. Immediate family or close relative is a member of the office staff, including theInvestigator(s).

16. Females of childbearing potential (those who are not surgically sterilized orpostmenopausal) if they meet any one of the following:

• currently pregnant

• plan to become pregnant during the study

• breastfeeding