Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers

This study was a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over, daily-wear design involving two different silicone hydrogel toric lens types. Each lens type will be worn bilaterally for approximately one month.

Inclusion criteria

• Is between 18 and 39 years of age (inclusive) and has full legal capacity to volunteer;
• Has read and signed an information consent letter;
• Self-reports having a full eye examination in the previous two years;
• Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Habitually wears of toric soft contact lenses binocularly.

• No more than 1/3 of the participants should be wearing daily disposable soft toric lenses;
• the remaining 2/3+ of the participants must be planned frequent replacement soft toric lens wearers as follows:

• i. TOTAL30 for Astigmatism: maximum of 3 (∼10%) (no target percentage)
• ii. Biofinity toric: maximum of 13 (∼40%) (PLUS a target of minimum 10 (∼30%))
• iii. Air Optix for Astigmatism (inclusive of +Hydraglyde): maximum of 10 (∼30%) (PLUS a target of minimum 7 (∼20%))
• iv. ULTRA for Astigmatism: maximum of 5 (∼15%) (no target percentage)
• v. Acuvue Vita for Astigmatism: maximum of 3 (∼10%) (no target percentage)
• vi. Acuvue Oasys for Astigmatism: maximum of 10 (∼30%) (no target percentage)
• vii. Other brands of frequent replacement: maximum of 7 (∼20%) (no target percentage)
• Has refractive astigmatism of at least -0.75DC but no more than -2.75DC in each eye that is correctable with a soft toric lens with a cylinder power of no greater than -2.25DC;
• Is ammetropic and requires a spectacle spherical component of +8.00 to -10.00D inclusively;
• Can be fit and achieve binocular distance vision of at least 20/32 Snellen with the available lens parameters

Exclusion criteria

• Is participating in any concurrent clinical or research study;
• Has any known active ocular disease and/or infection that contraindicates contact lens wear;
• 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 contact lens wear or a study outcome variable;
• Has known sensitivity to the diagnostic sodium fluorescein used in the study;
• Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
• Has undergone refractive error surgery or intraocular surgery.