Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Inclusion Criteria:

• Normal eyes (other than correction for visual acuity);
• Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
• Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
• Other protocol-defined 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;
• Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
• History of intolerance or hypersensitivity to any component of the investigational products;
• Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
• Moderate, severe, abnormal, or other ocular findings;
• Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
• Any systemic disease at Visit 1 (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;
• Ocular surgery within the last 12 months;
• Other protocol-defined exclusion criteria may apply.