Clinical Evaluation of the Safety and Efficacy of FID 120947A

The purpose of this study is to evaluate the safety and efficacy of FID 120947A in soft contact lens wearers of Japanese ethnicity.

Inclusion Criteria:

• Successful history of silicone hydrogel or other soft contact lens wear (except for daily disposable lenses) in both eyes during the past 3 months and history of at least 5 consecutive days of successful DAILY wear in both eyes at Visit 1;
• Best spectacle corrected distance visual acuity greater than or equal to 0.8 (decimal visual acuity) in each eye;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Any ocular or systemic medical condition that may, in the opinion of the Investigator, preclude safe administration of the investigational products or affect the results of this study;
• Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Use of a daily cleaner and/or enzyme cleaner to care for lenses at least 7 days prior to Visit 1 (use of lens rewetting drops is acceptable);
• History of intolerance or hypersensitivity to any component of the investigational products;
• Unwilling or unable to abstain from use of all over-the-counter (OTC) or prescribed topical ocular medications (except for rewetting drops) within 7 days prior to Visit 1 and for the duration of the study;
• Moderate (grade 3) or severe (grade 4) corneal edema, corneal staining, injection (limbal hyperemia, bulbar conjunctival hyperemia), tarsal abnormalities, or "other" findings;
• Corneal vascularization that is mild (grade 2) or higher;
• Conjunctival or structural lid abnormalities or abnormal corneal opacities at Visit 1;
• Current or history of ocular infection, severe inflammation or disease within 6 months prior to Visit 1;
• Any systemic disease (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
• Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen for a minimum of 30 days prior to Visit 1;
• Ocular or intra-ocular surgery and/or ocular trauma within the last 12 months (excluding placement of punctal plugs);
• Participation in any investigational clinical study within 30 days of Visit 1;
• Other protocol-specified exclusion criteria may apply.