Comparison of Somofilcon A Daily Disposable Test Contact Lens and Somofilcon A Daily Disposable Control Contact Lens

Comparison of Daily Disposable Invigor I (Test) and Select 1 Day Lenses

The purpose of this study is to investigate the overall clinical performance of the somofilcon A daily disposable test soft contact lens compared to the somofilcon A daily disposable control soft contact lens.

The purpose of this study is to evaluate the clinical performance of an investigational silicone-hydrogel contact lens (test) against a marketed silicone-hydrogel contact lens (control) when worn on a daily disposable wear modality over 1 week (for each lens) in a randomized, bilateral, cross-over, dispensing study.

Inclusion Criteria:

• Is at least 17 years of age and has full legal capacity to volunteer;
• Has had a self-reported oculo-visual examination in the last two years;
• Has read, understood, and signed the information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Has a visual acuity of 20/30 or better (in each eye) with their habitual vision correction, or 20/20 best-corrected vision (for binocular distance acuity);
• Must be able to achieve 20/30 or better (in each eye) with the study lenses;
• Currently wears soft contact lenses for at least 3 days per week, 8 hours each day;
• Requires spectacle lens powers between -0.75 and -06.50 diopters sphere (0.25D steps);
• Has no more than 0.75 diopters of refractive astigmatism;
• Has clear corneas and no active* ocular disease;
• Has not worn lenses for at least 12 hours before the examination.

Exclusion Criteria:

• Is presently participating in any other clinical or research study including eye related clinical or research study;
• Has never worn contact lenses before.
• Has any systemic disease affecting ocular health.
• Has any active* ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
• Is using any systemic or topical medications that will affect a study outcome variable, and/or ocular health.
• Has any known sensitivity to fluorescein dye or products to be used in the study.
• Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
• Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
• Is aphakic.
• Has undergone corneal refractive surgery.
• Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).