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

NCT ID: NCT02189863

Last Updated: 2016-02-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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 simulation for each of the two treatments. A fresh pair of lenses was dispensed for the assessment. Subjects also wore lotrafilcon B single vision distance (SVD) and comfilcon A MF contact lenses during Period 1 and Period 2 respectively for an additional same-day assessment. Habitual correction was worn for an acclimatization drive in the driving simulator during Period 1.

Conditions

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Presbyopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Blinding Strategy

SINGLE

Investigators

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

Group Type OTHER

Lotrafilcon B MF

Intervention Type DEVICE

Multifocal contact lenses worn in both eyes

Lotrafilcon B MV

Intervention Type DEVICE

Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near

Lotrafilcon B SVD

Intervention Type DEVICE

Spherical contact lenses worn with both eyes corrected for distance

Comfilcon A MF

Intervention Type DEVICE

Multifocal contact lenses worn in both eyes

Habitual contact lenses

Intervention Type DEVICE

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

Group Type OTHER

Lotrafilcon B MF

Intervention Type DEVICE

Multifocal contact lenses worn in both eyes

Lotrafilcon B MV

Intervention Type DEVICE

Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near

Lotrafilcon B SVD

Intervention Type DEVICE

Spherical contact lenses worn with both eyes corrected for distance

Comfilcon A MF

Intervention Type DEVICE

Multifocal contact lenses worn in both eyes

Habitual contact lenses

Intervention Type DEVICE

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

Intervention Type DEVICE

Lotrafilcon B MV

Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near

Intervention Type DEVICE

Lotrafilcon B SVD

Spherical contact lenses worn with both eyes corrected for distance

Intervention Type DEVICE

Comfilcon A MF

Multifocal contact lenses worn in both eyes

Intervention Type DEVICE

Habitual contact lenses

Contact lenses worn in both eyes per subject's habitual prescription

Intervention Type DEVICE

Other Intervention Names

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AIR OPTIX® Aqua Multifocal AOAMF AIR OPTIX® Aqua AOAMV AIR OPTIX® Aqua Biofinity® Multifocal

Eligibility Criteria

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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.

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.
Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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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