Clinical Evaluation of Etafilcon A Contact Lenses Using a Novel Manufacturing Technology

Exclusion Criteria

• •Potential subjects who meet any of the following criteria will be excluded from participating in the study:
• •1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• •2. Any systemic disease, autoimmune disease, or use of medication that may interfere with contact lens wear.
• •3. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• •4. Any ocular infection.
• •5. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• •6. Monovision or multi-focal contact lens correction.
• •7. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• •8. History of binocular vision abnormality or strabismus.
• •9. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self-report).
• •10. Suspicion of or recent history of alcohol or substance abuse.
• •11. History of serious mental illness.
• •12. History of seizures.
• •13. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician)
• •14. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with contact lens wear and/or participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or corneal distortion
• •15. Any Grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Food and Drug Administration (FDA) classification scale
• •16. 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 ocular abnormality that may contraindicate contact lens wear.