Presbyopia
Conditions
Keywords
Driving Simulator, Air Optix Aqua, AOAMF
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.
Interventions
DEVICELotrafilcon B MF
Multifocal contact lenses worn in both eyes
DEVICELotrafilcon B MV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
DEVICELotrafilcon B SVD
Spherical contact lenses worn with both eyes corrected for distance
DEVICEComfilcon A MF
Multifocal contact lenses worn in both eyes
DEVICEHabitual contact lenses
Contact lenses worn in both eyes per subject's habitual prescription
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
Subjects were recruited from 2 investigational sites located in the UK.
Pre-assignment details
Of the 33 enrolled, 6 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants who successfully tried at least one study lens (27).
Participants by arm
| Arm | Count |
|---|---|
| Overall Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First 2 Weeks | Motion Sickness | 4 | 2 |
Baseline characteristics
| Characteristic | Overall |
|---|---|
| Age, Continuous | 55.4 years STANDARD_DEVIATION 5.4 |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 25 | 1 / 23 | 2 / 23 | 0 / 21 | 2 / 27 |
| serious Total, serious adverse events | 0 / 25 | 0 / 23 | 0 / 23 | 0 / 21 | 0 / 27 |
Outcome results
Primary
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.
Time frame: Week 2, each period
Population: This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AOAMV | Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds) | 1.89 seconds | Standard Deviation 0.22 |
| AOAMF | Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds) | 1.88 seconds | Standard Deviation 0.19 |
Secondary
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.
Time frame: Week 2, each period
Population: This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| AOAMV | Standard Deviation of Lateral Positioning | 0.35 meters | Standard Deviation 0.06 |
| AOAMF | Standard Deviation of Lateral Positioning | 0.35 meters | Standard Deviation 0.05 |