A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.

Inclusion Criteria:

• Informed Consent and HIPAA document read, signed, and dated.
• Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
• Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

Exclusion Criteria:

• History of hypersensitivity
• Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
• One functional eye or a monofit eye
• Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
• Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
• Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
• Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
• Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
• Abnormal lenticular opacity in the visual axis of the lens in either eye
• Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
• History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
• Pregnant or lactating females