NCT02189863

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	Lotrafilcon B MF	Multifocal contact lenses worn in both eyes
DEVICE	Lotrafilcon B MV	Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
DEVICE	Lotrafilcon B SVD	Spherical contact lenses worn with both eyes corrected for distance
DEVICE	Comfilcon A MF	Multifocal contact lenses worn in both eyes
DEVICE	Habitual contact lenses	Contact lenses worn in both eyes per subject's habitual prescription

Timeline

• Start date: 2014-08-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-07-15
• Last updated: 2016-02-18
• Results posted: 2016-01-20