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.

Study Overview

• Status: Completed
• Conditions: Presbyopia
• Intervention / Treatment: Device: Lotrafilcon B MF; Device: Lotrafilcon B MV; Device: Lotrafilcon B SVD; Device: Comfilcon A MF; Device: Habitual contact lenses

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: AIR OPTIX® Aqua; Device: Comfilcon A MF; Multifocal contact lenses worn in both eyes; Other Names: Biofinity® Multifocal; Device: Habitual contact lenses; Contact lenses worn in both eyes per subject's habitual prescription
Other: 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 Names: AIR OPTIX® Aqua; Device: Comfilcon A MF; Multifocal contact lenses worn in both eyes; Other Names: Biofinity® Multifocal; Device: Habitual contact lenses; Contact lenses worn in both eyes per subject's habitual prescription

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)	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.	Week 2, each period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standard Deviation of Lateral Positioning	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.	Week 2, each period

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Sr. Clinical Manager, Global Medical Affairs, Vision Care, Alcon Research

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: July 11, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): February 18, 2016
• Last Update Submitted That Met QC Criteria: January 21, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Driving Simulator; Air Optix Aqua; AOAMF
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: M-14-009