An interventional study of Lotrafilcon B MF and Lotrafilcon B MV in Presbyopia, sponsored by Alcon Research. Completed. Open to participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2016-02-18.
Sponsored by Alcon Research · Not applicable and Interventional
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.
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.
324 studies on the registry are indexed under Presbyopia; 33 are open to participants now.
This study's enrollment of 33 is below the median of 61 across 265 interventional studies indexed under Presbyopia.
Browse Presbyopia studies →Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
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 · Device: Lotrafilcon B MV · Device: Lotrafilcon B SVD · Device: Comfilcon A MF · Device: Habitual contact lenses
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 · Device: Lotrafilcon B MV · Device: Lotrafilcon B SVD · Device: Comfilcon A MF · Device: Habitual contact lenses
Multifocal contact lenses worn in both eyes
Also known as: AIR OPTIX® Aqua Multifocal, AOAMF
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
Also known as: AIR OPTIX® Aqua, AOAMV
Spherical contact lenses worn with both eyes corrected for distance
Also known as: AIR OPTIX® Aqua
Multifocal contact lenses worn in both eyes
Also known as: Biofinity® Multifocal
Contact lenses worn in both eyes per subject's habitual prescription
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
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
Subjects were recruited from 2 investigational sites located in the UK.
| Milestone | AOAMV, Then AOAMF | AOAMF, Then AOAMV |
|---|---|---|
| Started | 12 | 15 |
| Completed | 8 | 13 |
| Not completed | 4 | 2 |
| Withdrew: Motion sickness | 4 | 2 |
| Milestone | AOAMV, Then AOAMF | AOAMF, Then AOAMV |
|---|---|---|
| Started | 8 | 13 |
| Completed | 8 | 13 |
| Not completed | 0 | 0 |
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.
| seconds | AOAMV | AOAMF |
|---|---|---|
| Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds) | 1.89 ± 0.22 | 1.88 ± 0.19 |
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.
| meters | AOAMV | AOAMF |
|---|---|---|
| Standard Deviation of Lateral Positioning | 0.35 ± 0.06 | 0.35 ± 0.05 |
Collected over Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 4 weeks). This analysis group includes all randomized subjects who successfully tried at least one study lens, based on treatment-specific exposure.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AOAMV | — | 0/25 (0%) | 1/25 (4%) |
| AOAMF | — | 0/23 (0%) | 1/23 (4.3%) |
| Lotra B SVD | — | 0/23 (0%) | 2/23 (8.7%) |
| Biofinity MF | — | 0/21 (0%) | 0/21 (0%) |
| Habitual | — | 0/27 (0%) | 2/27 (7.4%) |
| Event | AOAMV | AOAMF | Lotra B SVD | Biofinity MF | Habitual |
|---|---|---|---|---|---|
| Motion sicknessGeneral disorders | 1/25 | 1/23 | 2/23 | 0/21 | 2/27 |
This analysis population includes all randomized participants who successfully tried at least one study lens.
| Age, Continuous(years) | Overall |
|---|---|
| Mean | 55.4 ± 5.4 |
| Sex: Female, Male(Participants) | Overall |
|---|---|
| Female | 17 |
| Male | 10 |
No study locations are listed for this record.
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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