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 |
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.
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.
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
Alcon Call Center Alcon is helping people see the world better through advanced surgical, pharmaceutical...
Click here to add this to my saved trials