Impact of Soft Contact Lenses on Lid-Parallel Conjunctival Folds

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 18 years old.
• The subject's contact lens correction must be in the range of -12.00 to +8.00 in each eye.
• The subject's refractive cylinder must be less than 1.50D in each eye.
• The subject must have best visual acuity of 20/40 or better in each eye.
• The subject must demonstrate adequate mobility and 20/40 vision OD and OS with their habitual contact lenses.
• The subject must be an adapted soft contact lens wearer in both eyes with at least 1 year experience in contact lens wear.
• The subject must have normal eyes (i.e. no ocular medications or infections of any type).
• The subject must have Lid-Parallel Conjunctival Folds greater than or equal to grade 1 OD or OS.

Exclusion criteria

• Currently self reported 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. This may include, but not be limited to, ocular/systemic pathology or allergy known to affect the conjunctiva, Sjogren's Syndrome, rheumatoid arthritis, diabetes, infections, hay-fever, or if they have had ocular surgery.
• Any systemic disease, autoimmune disease, or use of medication, which 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 intra-ocular 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 abnormality that may contraindicate contact lens wear.
• Any ocular infection.
• Monovision or multi-focal contact lens correction.
• Participation in any contact lens or lens care product clinical trial within 90 days prior to study enrollment.
• Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV,by self report).
• Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician)
• Contact lens wearing of OASYS or TruEye lenses
• Contact lens wearing time less than 6h/day and/or 5 days/week
• Extended wear of contact lenses.

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