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

Completed · Not applicable

Conditions studied: Corneal Staining

In brief

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.

Key facts

Study ID

NCT01335750

Run by

CooperVision, Inc.

People needed

32

Starts

2010-08-01

Expected to finish

2010-09-01

Last updated by the study team

2020-07-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Erdey/Searcy Eye Group — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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