Comparative Study of Two Marketed Spherical Soft Contact Lenses

This is an interventional treatment trial for Refractive Error Read More

Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

• Based on his/her knowledge, must be in good general health.
• Be 18 to 38 years old.
• Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
• Read, indicate understanding of, and sign Written Informed Consent.
• Be existing or successfully adapted users of soft contact lenses, but not currently wearing either of the study lenses being evaluated in this trial.
• Require a visual correction in both eyes.
• Require a prescription between +8.00D and -12.00D and have less than -0.75D of astigmatism in both eyes.
• Achieve visual acuity of 20/25 or better in each eye with a spherical contact lens prescription.
• Must be able to wear their lenses at least 10 working days over the next 2-weeks; > 8 hours/day assuming there are no contraindications for doing so.
• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia; no evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes); no clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 2 or above: corneal edema, tarsal abnormalities, and conjunctival injection); no other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea [infiltrates], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology); no aphakia

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

• Greater than 0.50D of refractive astigmatism in either eye.
• Presbyopic or current monovision contact lens wear.
• Cannot be currently wearing of either lenses (Avaira or Oasys)
• Presence of clinically significant (grade 2-4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
• Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
• Slit lamp findings that would contraindicate contact lens wear such as: pathological dry eye or associated findings; pterygium, pinguecula or corneal scars within the visual axis; neovascularization > 0.75 mm in from the limbus, giant papillary conjunctivitis (GPC) worse than Grade 1; anterior uveitis or iritis (past or present), seborrheic eczema, seborrheic conjunctivitis, history of corneal ulcer or fungal infections; poor personal hygiene
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Contact lens best corrected Snellen visual acuities (VA) worse than 20/30.
• Aphakia, Keratoconus or a highly irregular cornea

To be eligible to enter the study, subjects must have ALL of the inclusion criteria and NONE of the exclusion criteria present.