The overall objective of this study is to compare the effect on simulated driving performance of multifocal (MF) versus monovision (MV) soft contact lenses in mid-late presbyopes.

In this crossover study, subjects wore lotrafilcon B MV (AOAMV) and lotrafilcon B MF (AOAMF) soft contact lenses as randomized for 2 weeks each. Subjects were assessed using a standardised driving simulation for each of the two treatments. A fresh pair of lenses was dispensed for the assessment. Subjects also wore lotrafilcon B single vision distance (SVD) and comfilcon A MF contact lenses during Period 1 and Period 2 respectively for an additional same-day assessment. Habitual correction was worn for an acclimatization drive in the driving simulator during Period 1.

Inclusion Criteria:

• Current soft contact lens wearers (for 1 month or more) with distance spherical power requirements of +1.00 to + 4.00 diopters (D) or -1.00 to -10.00D, and who have never tried and then failed in monovision or AOAMF.
• Medium to high presbyopia, i.e. spectacle add requirement of +1.50D or more.
• Astigmatism, if present, ≤1.00D in both eyes.
• Distance visual acuity (VA) correctable to 20/30 (+0.2 logMAR) in both eyes.
• Within the normal ranges for binocular vision for distance (8Δ exophoria, ≤8Δ esophoria), vertical phoria = 1.5Δ hypo or hyper.
• Full United Kingdom driving license held for at least 3 years, with at least 2000 miles driven per year.
• Willing to wear study lenses at least 5 days per week.
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Existing AIR OPTIX® Multifocal CL user.
• Sphere requirement in the range +0.75 to -0.75D in both eyes.
• Previous refractive surgery.
• Ocular/systemic medical condition or medical treatment contra-indicating contact lens wear or driving simulation.
• Participation in a clinical study within the past 30 days.
• Other protocol-defined exclusion criteria may apply.

This analysis population includes all randomized participants who successfully tried at least one study lens.

Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 4 weeks). This analysis group includes all randomized subjects who successfully tried at least one study lens, based on treatment-specific exposure.

An AE was defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the medical device. Ocular adverse events are presented for both study eye and non-study eye.