Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Inclusion Criteria:

• Must sign an informed consent form;
• Habitual current daily disposable soft contact lenses wearer;
• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
• Lenses within the power range specified in the protocol;
• Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
• Acceptable lens fit with both study contact lenses;
• Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Currently wearing DT1 or TE sphere lenses;
• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
• Eye injury or surgery within 12 weeks immediately prior to enrollment;
• History of herpetic keratitis, ocular surgery or irregular cornea;
• Prior refractive surgery;
• Monocular (only 1 eye with functional vision) or fit with only 1 lens;
• Participation in any clinical trial within 30 days of the enrollment visit;
• Other protocol-specified exclusion criteria may apply.