DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids

The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Inclusion Criteria:

• Sign an informed consent document;
• Adapted, current soft contact lens wearer;
• Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
• Can be successfully fitted with study lenses;
• Willing to wear lenses for a minimum of 8 hours prior to each study visit;
• Willing to discontinue artificial tears and rewetting drops usage on the days of study visits;
• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular (only 1 eye with functional vision) or fit with only one lens;
• History of herpetic keratitis, ocular surgery, or irregular cornea;
• Known pregnancy and lactation;
• Other protocol-specified exclusion criteria may apply.