A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

A 6-Hour Clinical Evaluation of New Daily-Wear Soft Contact Lenses

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control).

The purpose of this study is to validate the clinical performance of a new contact lens design when worn over a period of 6 hours compared to nelfilcon A (control). The primary outcomes of interest are lens fit and lens fit preference.

Inclusion Criteria:

• Is at least 18 years of age and has full legal capacity to volunteer
• Has read, fully understood and signed the information consent letter
• Currently wears or has previously worn soft contact lenses
• Has spectacle cylinder ≤1.00D in both eyes.
• Has spherical contact lens power requirement between -1.00D and -6.00D in both eyes.
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye.
• Has clear corneas and no active ocular disease
• Is willing and able to follow product usage instructions and maintain the visit schedule.

Exclusion Criteria:

• Has never worn contact lenses before
• 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 any known active ocular disease and/or infection
• Has a monovision correction
• Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses
• Is aphakic
• Has undergone corneal refractive surgery
• Is pregnant or lactating, determined by self-report