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

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Lotrafilcon B MF; Device: Lotrafilcon B MV; Device: Lotrafilcon B SVD; Device: Comfilcon A MF; Device: Habitual contact lenses

• Registration Number: NCT02189863
• Lead Sponsor: Alcon Research

Brief 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.

Study Timeline

• Study First Submitted: 2014-07-11
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Study Start: 2014-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2015-12-14
• Results First Submitted QC: 2015-12-14
• Status Verified: 2016-01
• Results First Posted: 2016-01-20
• Last Update Submitted: 2016-01-21
• Last Update Posted: 2016-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AOAMV, then AOAMF	Comfilcon A MF	Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2
AOAMF, then AOAMV	Lotrafilcon B MF	Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
AOAMF, then AOAMV	Comfilcon A MF	Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
AOAMV, then AOAMF	Lotrafilcon B MF	Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2
AOAMF, then AOAMV	Lotrafilcon B SVD	Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
AOAMF, then AOAMV	Habitual contact lenses	Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
AOAMV, then AOAMF	Lotrafilcon B MV	Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2
AOAMV, then AOAMF	Habitual contact lenses	Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2
AOAMV, then AOAMF	Lotrafilcon B SVD	Lotrafilcon B MV contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses worn for 2 weeks in Period 2
AOAMF, then AOAMV	Lotrafilcon B MV	Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2

Primary Outcome Measures

Name	Time	Method
Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)	Week 2, each period	Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.

Secondary Outcome Measures

Name	Time	Method
Standard Deviation of Lateral Positioning	Week 2, each period	The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.