Bilateral Dispensing Clinical Trial of Stenfilcon A Against Etafilcon A for Astigmatism

CooperVision is evaluating the clinical performance of an FDA cleared silicone-hydrogel lens
material stenfilcon A (test) compared to enfilcon A for Astigmatism lens (control) when worn
on a daily wear basis over one (1) week in a randomized, bilateral, cross-over, dispensing
study.

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 a spherical contact lens prescription between -1.00 to -6.00 inclusive in
each eye

- Has spectacle astigmatism: -0.50 to -1.50D cylinder (Axis: 90±20, 180±20 in both
eyes);

- Willing to wear contact lens in both eyes for at least 8 hours per day, 7 days per
week;

- 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 (by verbal confirmation at the screening visit);

- Is aphakic;

- Has undergone refractive error surgery