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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any - 70
Updated:2/7/2015
Start Date:August 2014
End Date:December 2014
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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The overall objective of this study is to compare the effect on simulated driving
performance of multifocal versus monovision soft contact lenses in mid-late presbyopes.

In this crossover study, subjects will wear MV and MF soft contact lenses (CL) in random
succession for 2 weeks each. Subjects will be assessed using a standardised driving
simulation for each of the two treatments. Subjects will also wear SVD or BM respectively
immediately after the MV and MF pairs for an additional same-day assessment. An exit visit
will be conducted 14 days after the conclusion of second 2-week period.

Inclusion Criteria:

- Current soft contact lens wearers (for 1 month or more) with distance spherical CL
power requirements of +1.00 to + 4.00 diopters (D) or -1.00 to -8.00D, 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.
We found this trial at
1
site
6201 South Freeway
Fort Worth, Texas 76134
800 862 5266
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