a clinical trial to evaluate investigational silicone hydrogel contact lenses worn continuously for one week

Conditions: Visual Disorder

Summary: this study is a prospective, randomized, double-masked, bilateral, dispensing, parallel-group clinical trial design. all subjects will participate in a 2-week daily disposable contact lens adaptation period prior to being randomized into one of the four extended wear lenses. the study has a total of 9 scheduled study visits and a total duration of \~197 days. the lenses will be replaced with a fresh pair after 6 nights / 7 days of wear.


Eligibility criteria:
inclusion criteria: * the subject must read and understand english 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 no more than 39 years of age. * the subject's spherical equivalent distance refraction must be in the range of -1.00 to -5.50 diopters in each eye. * the subject's refractive cylinder must be less than 1.00 diopters in each eye. * the subject must have best corrected visual acuity of 20/30 or better in each eye. * the subject must be without history of contact lens use in the past 12 months. * the subject must have normal eyes (i.e., no ocular medications or infections of any type). exclusion criteria: * any previous experience wearing contact lenses on an overnight or extended wear basis (at least 1 night per month) * currently pregnant or lactating (self reported) (subjects who become pregnant during the study will be discontinued). * currently a regular smoker (1 or more times per month). * current routine swimmer (1 or more times per month). * any ocular or systemic allergies or diseases that may interfere with contact lens wear. * any systemic disease (ex. sjögren's syndrome), autoimmune disease (ex. rheumatoid arthritis), or use of medication (ex. chronic steroid use), 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 interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (prk), laser in situ keratomileusis (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 ocular infection. * any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear. * participation in any contact lens or lens care product clinical trial within 7 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). * employee of investigational clinic (e.g., investigator, coordinator, technician).