Status:
COMPLETED
Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
Lead Sponsor:
Alcon Research
Conditions:
Presbyopia
Eligibility:
All Genders
Up to 70 years
Phase:
NA
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 sim...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT02189863
Start Date
August 1 2014
End Date
December 1 2014
Last Update
February 18 2016
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