Clinical Performance of Senofilcon A Investigational Lens

Exclusion Criteria

• •The subject must not:
• •1. Be currently pregnant or lactating.
• •2. Be currently using any ocular medications or have any ocular infection of any type.
• •3. By self-report, have any ocular or systemic disease, allergies, infection, or use of medication that the investigator believes might contraindicate or interfere with contact lens wear, or otherwise compromise study endpoints, including infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive disease (e.g., Human Immunodeficiency Virus \[HIV\]), autoimmune disease (e.g. rheumatoid arthritis, Sjögren's syndrome), or history of serious mental illness or seizures. See section 9.1 for additional details regarding excluded systemic medications.
• •4. Have habitually worn rigid gas permeable (RGP) lenses, orthokeratology lenses, or hybrid lenses (e.g. SynergEyes, SoftPerm) within the past 6 months.
• •5. Be currently wearing monovision or multifocal contact lenses.
• •6. Be currently wearing lenses in an extended wear modality.
• •7. Have participated in a contact lens or lens care product clinical trial within 30 days prior to study enrollment.
• •The subject must not:
• •9. Have clinically significant (grade 3 or higher on the FDA grading scale) slit lamp findings (e.g., corneal edema, neovascularization or staining, tarsal abnormalities or bulbar injection) or other corneal or ocular disease or abnormalities that the investigator believes might contraindicate contact lens wear or may otherwise compromise study endpoints (including entropion, ectropion, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, moderate or above corneal distortion, herpetic keratitis). (Specify method of determination if needed).
• •10. Have a history of strabismus or amblyopia.
• •11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
• •12. Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).