Vistakon Investigational Contact Lenses Worn for Daily Wear

Exclusion Criteria

• •1. The subject must be free of Grade 2 or greater slit lamp findings (edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection, and other ocular abnormality), which would contraindicate contact lens wear.
• •2. Any active ocular (i.e. corneal infiltrates, conjunctiva, lids, and intraocular) infection or inflammation of an allergic, bacterial, or viral etiology.
• •3. Entropion, ectropion, chalazia, recurrent styes, glaucoma or glaucoma suspect, history of recurrent corneal erosions and aphakia.
• •4. The following medications are prohibited (at lease one week prior to enrollment): oral retinoid isoretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. antihistamines (e.g. Seldane, Chlor-Trimeton, and Benadryl), and ophthalmic antihistamic Beta-adrenergic blockers (e.g. Propranolol, Timolol, and Practolol), systemic steroids, and and prescribed or OTC ocular medication. Any prescription or PTC medications or preparations containing silver.
• •5. Moderate or above corneal distortion by keratometry.
• •6. Known allergy to silver, silver ions, or silver containing compounds.
• •7. Abnormal discoloration of the cornea and/or conjunctiva.
• •8. Routine exposure to silver, silver ions, or silver containing compounds.
• •9. The subject must be free of systemic diseases which may interfere with contact lens wear: diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjogren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases (e.g. AIDS)
• •10. Free of systemic and infectious diseases: hepatitis and tuberculosis.
• •11. Subjects must be HIV negative.
• •12. The subject must not be currently be pregnant or lactating (Subject becoming pregnant during the study will be discontinued).
• •13. The subject's eyes must be best corrected to a visual acuity of 20/30 or better in each eye.
• •14. The subject must not have more than 1.00D of refractive astigmatism in either eye.
• •15. The subject's distance spherical contact lens prescription must be between -1.00D and -6.00D.
• •16. The subject must not be monovision corrected.
• •17. The subject must have no history of solution reaction to Opti-free RepleniSH MPDS-No Rub Solution.
• •18. The subject must not have any previous history or signs of a contact lens related corneal inflammatory event (i.e. past peripheral ulcers or round peripheral scars)
• •19. The subject must not have participated in a device or pharmaceutical clinical trial within 30 days prior to study enrollment.
• •20. The subject must not have had an eye injury within 8 weeks prior to study enrollment.
• •21. The subject must not have had previous eye surgery.
• •22. The subject must be successfully trial fitted with the study contact lenses.