N/A
Completed N=27
Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
Source: ClinicalTrials.gov NCT02189863 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds) — 1.89; 1.88 seconds
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds) |
1.89; 1.88 | — |
| SECONDARY Standard Deviation of Lateral Positioning |
0.35; 0.35 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02189863). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.