evaluation of the coopervision, inc. fanfilcon a and enfilcon a daily wear contact lenses when used for frequent replacement for up to one (1) month of daily wear

Conditions: Myopia

Summary: this study is a masked, multi-center, daily wear, monthly replacement, bilateral, randomized, lens blocked (subjects remain in the same lens brand throughout the study) concurrent control study enrolling up to 90 subjects with a study duration of approximately three months. subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon a lens (test) to enfilcon a lens (control).

subjects will be randomized into the study contact lenses in a two to one (2:1) ratio of fanfilcon a lens (test) to enfilcon a lens (control). this should result in a study population of approximately 60 test subjects and 30 control subjects.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age as of the date of evaluation for the study. * have: * read the informed consent * been given an explanation of the informed consent * indicated understanding of the informed consent * signed the informed consent document. * be willing and able to adhere to the instructions set forth in this protocol and able to keep all specified appointments. * be an adapted, current full-time silicone hydrogel or soft contact lens wearer. an adapted full-time wearer is defined as wearing contact lenses at least 5 days per week for at least 8 hours per day for at least one month prior to participation in the study. * possess or obtain prior to dispensing, wearable and visually functional (20/40 or better) eyeglasses. * be in good general health, based on his/her knowledge. * require spectacle lens powers between -0.50 and -8.00 diopters sphere with no more than 1.50 diopter of refractive astigmatism and be willing to wear contact lenses in both eyes. * have manifest refraction snellen visual acuities (va) equal to or better than20/25 in each eye. * to be eligible for lens dispensing, the subject must achieve 20/30 va or better in each eye with the study lens and the investigator must judge the fit as acceptable or optimal. exclusion criteria: * wearing lenses in a monovision modality and is unwilling to be fit with distance lenses in both eyes for the duration of the study. note: subjects may not wear lenses in a monovision modality at any time during the study as it will interfere with the visual acuity analysis. * poor personal hygiene. * any active participation in another clinical trial during this trial or within 30 days prior to this study. * to the best of the subject's knowledge, she is currently pregnant, is lactating or is planning a pregnancy within the next 3 months. * a member, relative or household member of the investigator or of the investigational office staff. * has a known sensitivity to the ingredients used in the multi-purpose disinfection lens care system (mps) approved for use in the study and is unable or unwilling to use the alternate care system. * previous refractive surgery; or current or previous orthokeratology treatment. * is aphakic or pseudophakic. * ocular or systemic disease such as, but not limited to: anterior uveitis or iritis (past or present), glaucoma, sjögren's syndrome, lupus erythematosus, scleroderma, keratoconus or uncontrolled diabetes. * the need for topical ocular medications or any systemic medication which might interfere with contact lens wear or require the lenses to be removed during the day. * the presence of clinically significant (grade 2, 3 or 4) anterior segment abnormalities; or the presence of any inflammations such as iritis; or any infection of the eye, lids, or associated structures. * a known history of corneal hypoesthesia (reduced corneal sensitivity), corneal ulcer, corneal infiltrates, iritis, bacterial or fungal infections. * a history of papillary conjunctivitis that has interfered with contact lens wear. * slit lamp findings that would contraindicate contact lens wear, including but not limited to: * pathological dry eye or associated dry eye symptoms with decreased tear levels and punctuate staining \> grade 2 * pterygium * corneal scars within the visual axis * neovascularization or ghost vessels \> 1.0 mm in from the limbus * giant papillary conjunctivitis (gpc) of \> grade 2 * anterior uveitis or iritis * seborrheic eczema, seborrheic conjunctivitis or blepharitis