Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

Comparative In-Vivo Wetting Characteristics of Silicone Hydrogel Materials With Selected Lens Care Systems

The purpose of this study is to evaluate the lipid uptake, wetting characteristics, and visual performance of AIR OPTIX® AQUA and ACUVUE® OASYS® with HYDRACLEAR® contact lenses when used in conjunction with two contact lens care systems.

This study will be divided into two phases. In the Pre-Investigational Phase (Phase 1), participants will wear PureVision contact lenses for 30 days and use ReNu® Multiplus® for contact lens care. Eligible participants will continue into the Investigational Phase (Phase 2) and be randomly assigned to wear AIR OPTIX® AQUA contact lenses or ACUVUE® OASYS® with HYDRACLEAR® contact lenses for a total of two months. For contact lens care, participants will use OPTI-FREE® PUREMOIST® MPDS and BIOTRUE® for 30 days each.

Inclusion Criteria:

• Read and understand the Participant Information Sheet;
• Read, sign, and date the Informed Consent;
• Be a current silicone hydrogel contact lens wearer using the contact lenses under a frequent replacement (bi-weekly or monthly) daily wear modality;
• Be classified as symptomatic and a depositor at the end of the replacement period according to protocol-specified criteria;
• Agree to wear study contact lenses as directed for the duration of the study and maintain the appointment schedule;
• Best corrected visual acuity of 6/9 or better in each eye;
• Normal eyes with the exception of the need for visual correction;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used;
• Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses);
• Use of systemic medication which might interfere with contact lens wear or produce dry eye side effects;
• Systemic disease which might interfere with contact lens wear or produce dry eye side effects;
• Systemic or ocular allergies which might interfere with contact lens wear;
• Ocular disease which might interfere with contact lens wear;
• Active ocular infection;
• Use of any concomitant topical ocular medications during the study period;
• Previous ocular surgery;
• Pregnant, planning to become pregnant, or lactating at the time of enrollment;
• Participation in an investigational drug or device study within 30 days of entering this study;
• Other protocol-defined exclusion criteria may apply.