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OpenTrials
Completed

NCT Number: NCT02189863

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

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.

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Key information

Conditions

Presbyopia Eye Diseases Refractive Errors

Age range

Up to 70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon B MF

Device

Multifocal contact lenses worn in both eyes

Other names: AIR OPTIX® Aqua Multifocal, AOAMF

Lotrafilcon B MV

Device

Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near

Other names: AIR OPTIX® Aqua, AOAMV

Lotrafilcon B SVD

Device

Spherical contact lenses worn with both eyes corrected for distance

Other names: AIR OPTIX® Aqua

Comfilcon A MF

Device

Multifocal contact lenses worn in both eyes

Other names: Biofinity® Multifocal

Habitual Contact Lenses

Device

Contact lenses worn in both eyes per subject's habitual prescription

Primary outcomes

  1. Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)

    Time frame: 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 outcomes

  1. Standard Deviation of Lateral Positioning

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jul 15, 2014
Registry last updated
Feb 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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