Clinical Evaluation of Manufacturing Processes for a Reusable Multifocal Optical Design in a Presbyopic Population

Exclusion Criteria

• •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• •1. Currently pregnant or lactating.
• •2. Any active or ongoing ocular or systemic allergies that may interfere with contact lens wear.
• •3. Any active or ongoing systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).
• •4. Clinically significant (Grade 3 or 4) corneal edema, corneal vascularization, corneal staining, tarsal abnormalities or bulbar injection, or any other corneal or ocular abnormalities which would contraindicate contact lens wear.
• •5. Entropion, ectropion, extrusions, chalazia, recurrent styes, dry eye, glaucoma, history of recurrent corneal erosions.
• •6. Any previous, or planned, ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, lid procedures, dacryocystorhinostomy cataract surgery, retinal surgery, etc.).
• •7. A history of amblyopia, strabismus or binocular vision abnormality.
• •8. Any current ocular infection or inflammation.
• •9. Any current ocular abnormality that may interfere with contact lens wear.
• •10. Use of any of the following oral medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, systemic steroids.
• •11. Use of any ocular medication, with the exception of rewetting drops.
• •12. History of herpetic keratitis.
• •13. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• •14. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
• •15. Any known hypersensitivity or allergic reaction to Optifree®Replenish® multipurpose care solution, sodium fluorescein or Eye-Cept® rewetting drop solution.