NCT02189863

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 11, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 15, 2014

Completed
17 days until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2016

Completed
Last Updated

February 18, 2016

Status Verified

January 1, 2016

Enrollment Period

4 months

First QC Date

July 11, 2014

Results QC Date

December 14, 2015

Last Update Submit

January 21, 2016

Conditions

Presbyopia

Keywords

Driving SimulatorAir Optix AquaAOAMF

Outcome Measures

Primary Outcomes (1)

  • Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)

    Driving reaction time to hazards was assessed during simulated night time driving and measured as time to brake, in seconds. One eye (study eye) contributed to the analysis. This outcome measure was prespecified for AOAMV and AOAMF.

    Week 2, each period

Secondary Outcomes (1)

  • Standard Deviation of Lateral Positioning

    Week 2, each period

Study Arms (2)

AOAMV, then AOAMF

OTHER

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

Device: Lotrafilcon B MFDevice: Lotrafilcon B MVDevice: Lotrafilcon B SVDDevice: Comfilcon A MFDevice: Habitual contact lenses

AOAMF, then AOAMV

OTHER

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

Device: Lotrafilcon B MFDevice: Lotrafilcon B MVDevice: Lotrafilcon B SVDDevice: Comfilcon A MFDevice: Habitual contact lenses

Interventions

Lotrafilcon B MFDEVICE

Multifocal contact lenses worn in both eyes

Also known as: AIR OPTIX® Aqua Multifocal, AOAMF
AOAMF, then AOAMVAOAMV, then AOAMF
Lotrafilcon B MVDEVICE

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

Also known as: AIR OPTIX® Aqua, AOAMV
AOAMF, then AOAMVAOAMV, then AOAMF
Lotrafilcon B SVDDEVICE

Spherical contact lenses worn with both eyes corrected for distance

Also known as: AIR OPTIX® Aqua
AOAMF, then AOAMVAOAMV, then AOAMF
Comfilcon A MFDEVICE

Multifocal contact lenses worn in both eyes

Also known as: Biofinity® Multifocal
AOAMF, then AOAMVAOAMV, then AOAMF
Habitual contact lensesDEVICE

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

AOAMF, then AOAMVAOAMV, then AOAMF

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Results Point of Contact

Title
Global Brand Lead, Global Medical Affairs, Vision Care
Organization
Alcon Research, Ltd.
alcon.medinfo@alcon.com
1-888-451-3937

Study Officials

  • Sr. Clinical Manager, Global Medical Affairs, Vision Care

    Alcon Research

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 11, 2014

First Posted

July 15, 2014

Study Start

August 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 18, 2016

Results First Posted

January 20, 2016

Record last verified: 2016-01