Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
NCT ID: NCT02189863
Last Updated: 2016-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2014-08-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SINGLE
Study Groups
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AOAMV, then AOAMF
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
Lotrafilcon B MF
Multifocal contact lenses worn in both eyes
Lotrafilcon B MV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
Lotrafilcon B SVD
Spherical contact lenses worn with both eyes corrected for distance
Comfilcon A MF
Multifocal contact lenses worn in both eyes
Habitual contact lenses
Contact lenses worn in both eyes per subject's habitual prescription
AOAMF, then AOAMV
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
Lotrafilcon B MF
Multifocal contact lenses worn in both eyes
Lotrafilcon B MV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
Lotrafilcon B SVD
Spherical contact lenses worn with both eyes corrected for distance
Comfilcon A MF
Multifocal contact lenses worn in both eyes
Habitual contact lenses
Contact lenses worn in both eyes per subject's habitual prescription
Interventions
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Lotrafilcon B MF
Multifocal contact lenses worn in both eyes
Lotrafilcon B MV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
Lotrafilcon B SVD
Spherical contact lenses worn with both eyes corrected for distance
Comfilcon A MF
Multifocal contact lenses worn in both eyes
Habitual contact lenses
Contact lenses worn in both eyes per subject's habitual prescription
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
70 Years
ALL
No
Sponsors
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Alcon Research
INDUSTRY
Responsible Party
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Principal Investigators
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Sr. Clinical Manager, Global Medical Affairs, Vision Care
Role: STUDY_DIRECTOR
Alcon Research
Other Identifiers
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M-14-009
Identifier Type: -
Identifier Source: org_study_id
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