A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks

To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.

This was a randomized, bilateral, 2 week cross over, double-masked, dispensing study comparing Sapphire test lens against the senofilcon A control lens. This study results were not used to support design validation of the test lens.

Inclusion Criteria:

• Is at least 17 years of age for Canada and 18 years of age for the USA 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;
• Is an adapted soft contact lens wearer
• Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
• Has no more than 0.75 diopters of refractive astigmatism
• Willing to wear contact lens in both eyes
• Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
• To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable

Exclusion Criteria:

• 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 (by verbal confirmation at the screening visit)
• Is aphakic
• Has undergone refractive error surgery