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

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ClinicalTrials.gov Identifier: NCT02189863
Recruitment Status : Completed
First Posted : July 15, 2014
Results First Posted : January 20, 2016
Last Update Posted : February 18, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Presbyopia Device: Lotrafilcon B MF Device: Lotrafilcon B MV Device: Lotrafilcon B SVD Device: Comfilcon A MF Device: Habitual contact lenses Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Investigator)
Official Title: Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
Study Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
AOAMV, then AOAMF
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
Device: Lotrafilcon B MF
Multifocal contact lenses worn in both eyes
Other Names:
  • AIR OPTIX® Aqua Multifocal
  • AOAMF

Device: Lotrafilcon B MV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
Other Names:
  • AIR OPTIX® Aqua
  • AOAMV

Device: Lotrafilcon B SVD
Spherical contact lenses worn with both eyes corrected for distance
Other Name: AIR OPTIX® Aqua

Device: Comfilcon A MF
Multifocal contact lenses worn in both eyes
Other Name: Biofinity® Multifocal

Device: Habitual contact lenses
Contact lenses worn in both eyes per subject's habitual prescription

AOAMF, then AOAMV
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
Device: Lotrafilcon B MF
Multifocal contact lenses worn in both eyes
Other Names:
  • AIR OPTIX® Aqua Multifocal
  • AOAMF

Device: Lotrafilcon B MV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
Other Names:
  • AIR OPTIX® Aqua
  • AOAMV

Device: Lotrafilcon B SVD
Spherical contact lenses worn with both eyes corrected for distance
Other Name: AIR OPTIX® Aqua

Device: Comfilcon A MF
Multifocal contact lenses worn in both eyes
Other Name: Biofinity® Multifocal

Device: Habitual contact lenses
Contact lenses worn in both eyes per subject's habitual prescription




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02189863


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Sr. Clinical Manager, Global Medical Affairs, Vision Care Alcon Research

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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02189863     History of Changes
Other Study ID Numbers: M-14-009
First Posted: July 15, 2014    Key Record Dates
Results First Posted: January 20, 2016
Last Update Posted: February 18, 2016
Last Verified: January 2016
Keywords provided by Alcon Research:
Driving Simulator
Air Optix Aqua
AOAMF
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases