Senofilcon A Investigational Manufacturing Process

Clinical Investigation of Senofilcon A Manufactured Using an Alternate Hydration Process

To evaluate the impact of a new contact lens hydration process

To evaluate the impact on clinical performance of senofilcon A lenses manufactured using an alternate hydration process and compare the performance with senofilcon A lenses manufactured using the current process.

Inclusion Criteria:

• The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
• The subject must be at least 18 and not more than 70 years of age.
• The subject's refractive cylinder must be < 0.75D in each eye.
• The subject must have best corrected visual acuity of 20/25 or better in each eye.
• The subject must demonstrate adequate mobility and 20/30 vision OD and OS with the study contact lenses.
• The subject must be a habitual and adapted wearer of ACUVUE® OASYS® Brand contact lens in both eyes.
• The subject must have normal eyes (i.e., no ocular medications or infections of any type).
• The subject's required spherical contact lens prescription must be in the range of -0.50 to -9.00D in each eye.

Exclusion Criteria:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
• Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
• Any systemic disease, autoimmune disease, or use of medication, that may interfere with contact lens wear.
• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
• 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.
• Any known hypersensitivity or allergic reaction to OPTI-FREE® PureMoist® Contact Lens Solution.
• Any ocular infection.
• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
• History of binocular vision abnormality or strabismus.
• Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV, by self report).
• Suspicion of or recent history of alcohol or substance abuse.
• History of serious mental illness.
• History of seizures.
• Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)