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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Presbyopia

Intervention / Treatment
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* Device: Lotrafilcon B MF
* Device: Lotrafilcon B MV
* Device: Lotrafilcon B SVD
* Device: Comfilcon A MF
* Device: Habitual contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AOAMV, then AOAMF<br>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<br>* Multifocal contact lenses worn in both eyes<br>* Other names: AOAMF;Device: Lotrafilcon B MV<br>* Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near<br>* Other names: AOAMV;Device: Lotrafilcon B SVD<br>* Spherical contact lenses worn with both eyes corrected for distance<br>* Other names: AIR OPTIX® Aqua;Device: Comfilcon A MF<br>* Multifocal contact lenses worn in both eyes<br>* Other names: Biofinity® Multifocal;Device: Habitual contact lenses<br>* Contact lenses worn in both eyes per subject's habitual prescription<br>|
| Other: AOAMF, then AOAMV<br>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<br>* Multifocal contact lenses worn in both eyes<br>* Other names: AOAMF;Device: Lotrafilcon B MV<br>* Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near<br>* Other names: AOAMV;Device: Lotrafilcon B SVD<br>* Spherical contact lenses worn with both eyes corrected for distance<br>* Other names: AIR OPTIX® Aqua;Device: Comfilcon A MF<br>* Multifocal contact lenses worn in both eyes<br>* Other names: Biofinity® Multifocal;Device: Habitual contact lenses<br>* Contact lenses worn in both eyes per subject's habitual prescription<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Driving Simulator, Air Optix Aqua, AOAMF