Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses

Alcon

Status

Completed

Conditions

Presbyopia

Treatments

Device: Comfilcon A MF

Device: Lotrafilcon B MF

Device: Lotrafilcon B MV

Device: Habitual contact lenses

Device: Lotrafilcon B SVD

Study type

Interventional

Funder types

Industry

Identifiers

NCT02189863

M-14-009

Details and patient eligibility

About

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.

Full description

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.

Enrollment

33 patients

Sex

All

Ages

Under 70 years old

Volunteers

No Healthy Volunteers

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.