Clinical Evaluation of An Approved Contact Lens

Exclusion Criteria

• •1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• •2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• •3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
• •4. Use of any medication with known tear film effects within 2 weeks prior to and during the study.
• •5. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion..
• •6. Any previous, or planned, ocular or interocular surgery (e.g. radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
• •7. Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, 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.
• •8. Any ocular infection.
• •9. Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV) by self-report.
• •10. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• •11. Participation in any contact lens or lens care product clinical trial within 7 days prior to study enrollment.
• •12. Employee of investigational clinic (e.g. Investigator, Coordinator, Technician).