Comparison of Verofilcon A Daily Disposable Lenses to Somofilcon A Daily Disposable Lenses

The study is a prospective, double masked (investigator and participant), bilateral, randomized,one week cross-over dispensing study, which evaluates somofilcon A (test lens) and verofilcon A (control lens).

Inclusion criteria

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A person is eligible for inclusion in the study if he/she:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
• Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
• Has an astigmatism of ≤ 1.00 D in subjective refraction;
• Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
• Demonstrates an acceptable fit with the study lenses;
• Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.

Exclusion criteria

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A person may be excluded from the study if he/she:

• Is participating in any concurrent clinical or research study;
• Has any known active* ocular disease and/or infection;
• Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
• Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
• Is pregnant, lactating or planning a pregnancy at the time of enrolment because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
• Is aphakic;
• Has undergone refractive error surgery;
• Is an employee of the Centre for Ocular Research & Education;
• Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or MIKI (EX-MKTG-114) Study;
• Has participated in any clinical trials within a week prior to the study.