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

Exclusion Criteria

• •1. Subject is considered by the Investigator, to not be a suitable candidate for participation or it is not in the best interest of the subject to participate in the study.
• •2. Subjects who have worn rigid gas permeable (RGP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
• •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 the Investigator's opinion may have an effect on ocular health during the course of the study.
• •6. Subjects using any systemic or topical medications that will, in the Investigator's opinion, 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 ocular infections.
• •9. Subjects with an active ocular disease or who are using any ocular medication.
• •11. Subjects with any "Present" finding during the slit lamp examination that, in the Investigator'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 the central area), that in the Investigator's judgement, does not interfere with contact lens wear, are eligible for this study.
• •13. Subjects participating in any drug or device clinical investigation within 2 weeks prior to entry into this study (Screening Visit) and/or planning to do so during the period of study participation.
• •14. Subjects who are amblyopic.
• •15. Immediate family or close relative is a member of the office staff, including the Investigator(s).
• •16. Females of childbearing potential (those who are not surgically sterilized or postmenopausal) if they meet any one of the following:
• •* They are currently pregnant
• •* They plan to become pregnant during the study
• •* They are breastfeeding