Evaluation of Two Toric Soft Contact Lenses After Two Weeks of Wear

Dispensing, single-masked (subject-masked), randomized, 2-visit controlled study of two-weeks duration.

Inclusion criteria

Prior to being considered eligible to participate in this study, subjects MUST

• be at least 18 and less than or equal to 39 years of age and have a need for vision correction in BOTH eyes (monovision or uniocular fitting is NOT allowed).
• be of Asian descent (Japanese, Chinese, Korean, Polynesian or other Asian ancestry) and have Asian Eye anatomy.
• have successfully worn toric or spherical soft (hydrogel or silicone hydrogel) contact lenses for at least 4-weeks prior to enrollment in the study.
• be able and willing to adhere to the instructions set forth in the protocol.
• agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
• have a distance spherical component between -1.00 D and -5.50 D with cylinder in the range of 0.75 D to 2.25 D and cylinder axis within 10 ° of the vertical and within 20 ° of the horizontal in both eyes
• have a best corrected manifest refraction visual acuity of at least 20/25 or better in each eye.
• be in good general health, based on his/her knowledge.
• read, be given an explanation of, indicate understanding of, and sign the STATEMENT OF INFORMED CONSENT.

Exclusion criteria

• The subject is a rigid gas permeable (RGP) or daily disposable soft lens wearer.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjögren's syndrome, type II diabetes, etc).
• Slit lamp findings that would contraindicate contact lens wear such as:

• Pathological dry eye or associated findings
• Pterygium or corneal scars within the visual axis
• Neovascularization >1mm in from the limbus
• History of giant papillary conjunctivitis (GPC) worse than Grade 2
• Anterior uveitis or iritis (past or present)
• Seborrhoeic eczema, seborrhoeic conjunctivitis
• A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
• A known history of corneal hypoesthesia (reduced corneal sensitivity.)
• Aphakia, keratoconus or a highly irregular cornea.
• Current pregnancy or lactation (to the best of the subject's knowledge).
• Active participation in another clinical study at any time during this study.