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

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Primary Outcome Measures

Name	Time	Method
Corneal Staining Severity	Baseline, 2 Hour Period, 4 Hour Period	Severity of staining was recorded for each region using a scale of 0-none to 4-patch \>/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.
Corneal Staining Area	Baseline, 2 Hour Period, 4 Hour Period	Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.

Secondary Outcome Measures

Name	Time	Method
Subjective Comfort	Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours	Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)
Subjective Dryness	Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours	Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)