PresbyopiaNCT02189863

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

A study testing Lotrafilcon B MF, Lotrafilcon B MV and Lotrafilcon B SVD in people with Presbyopia, run by Alcon Research.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages Up to 70 years
Conditions the study is for: Presbyopia
What is being tested?: Lotrafilcon B MF, Lotrafilcon B MV and Lotrafilcon B SVD
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: No sites listed yet
Study dates: Aug 2014to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 70 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.
Other protocol-defined inclusion criteria may apply.

Who cannot join

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.

About this study

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.

Read the detailed description

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: Presbyopia
Being tested: Lotrafilcon B MF, Lotrafilcon B MV, Lotrafilcon B SVD, Comfilcon A MF, Habitual contact lenses
Keywords: Driving Simulator, Air Optix Aqua, AOAMF
Medical subject headings: Presbyopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Lotrafilcon B MFDevice
Also called AIR OPTIX® Aqua Multifocal, AOAMF
Multifocal contact lenses worn in both eyes
Lotrafilcon B MVDevice
Also called AIR OPTIX® Aqua, AOAMV
Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
Lotrafilcon B SVDDevice
Also called AIR OPTIX® Aqua
Spherical contact lenses worn with both eyes corrected for distance
Comfilcon A MFDevice
Also called Biofinity® Multifocal
Multifocal contact lenses worn in both eyes
Habitual contact lensesDevice
Contact lenses worn in both eyes per subject's habitual prescription

Study groups in NCT02189863
Study group	Role	What they receive
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 Receives: Device: Lotrafilcon B MF; Device: Lotrafilcon B MV; Device: Lotrafilcon B SVD; Device: Comfilcon A MF; Device: 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 Receives: Device: Lotrafilcon B MF; Device: Lotrafilcon B MV; Device: Lotrafilcon B SVD; Device: Comfilcon A MF; Device: Habitual contact lenses

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Week 2, each period

Secondary outcomes (1)

Standard Deviation of Lateral Positioning
The standard deviation of lateral positioning (staying in the lane) was assessed during simulated night time driving and measured as the distance of deviation from the reference point, in meters. This outcome measure is prespecified for AOAMV and AOAMF.
Measured: Week 2, each period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2014Dec 2014

First posted15 Jul 2014 (estimated)
Study startAug 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PresbyopiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02189863
Sponsor's protocol ID: M-14-009
Status last verified: Jan 2016
First submitted: 11 Jul 2014
Last updated: 18 Feb 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Evaluation of Functional Superiority of the Morrow eProgressive
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Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
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Clinical Trial With Artiflex Presbyopic (Artiplus)
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All Presbyopia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Driving Simulator Study Comparing Two Modes of Presbyopic Correction With Contact Lenses
ClinicalTrials.gov ID: NCT02189863
Acronym / sponsor ID: M-14-009
Conditions: Presbyopia
Keywords: Driving Simulator, Air Optix Aqua, AOAMF
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Aug 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 15 Jul 2014 (estimated)
Results: Posted 20 Jan 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
AOAMV, then AOAMF	Other	Device: Lotrafilcon B MF, Device: Lotrafilcon B MV, Device: Lotrafilcon B SVD, Device: Comfilcon A MF, Device: Habitual contact lensesLotrafilcon 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
AOAMF, then AOAMV	Other	Device: Lotrafilcon B MF, Device: Lotrafilcon B MV, Device: Lotrafilcon B SVD, Device: Comfilcon A MF, Device: Habitual contact lensesLotrafilcon 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

Who may qualify

Ages: Up to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Lotrafilcon B MFAlso: AIR OPTIX® Aqua Multifocal, AOAMFMultifocal contact lenses worn in both eyes	Device	AOAMF, then AOAMV, AOAMV, then AOAMF
Lotrafilcon B MVAlso: AIR OPTIX® Aqua, AOAMVSpherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near	Device	AOAMF, then AOAMV, AOAMV, then AOAMF
Lotrafilcon B SVDAlso: AIR OPTIX® AquaSpherical contact lenses worn with both eyes corrected for distance	Device	AOAMF, then AOAMV, AOAMV, then AOAMF
Comfilcon A MFAlso: Biofinity® MultifocalMultifocal contact lenses worn in both eyes	Device	AOAMF, then AOAMV, AOAMV, then AOAMF
Habitual contact lensesContact lenses worn in both eyes per subject's habitual prescription	Device	AOAMF, then AOAMV, AOAMV, then AOAMF

Primary outcome

Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)
Time frame: Week 2, each period
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.

1 secondary outcome

Standard Deviation of Lateral Positioning
Time frame: Week 2, each period

Results and safety

Results posted to the registry on 20 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
AOAMV, Then AOAMF	12	8
AOAMF, Then AOAMV	15	13

Primary outcome: Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds)

Time frame: Week 2, each period. Mean (Standard Deviation). Unit: seconds

Measure	AOAMV n = 21	AOAMF n = 21
Value	1.89 (0.22)	1.88 (0.19)

Population analysed: This analysis population includes all randomized subjects in the groups to which they were randomly assigned who successfully completed both study lens follow-up evaluations without a protocol deviation that was documented as impacting the assessment of the hypotheses (Per-Protocol).

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 4 weeks). This analysis group includes all randomized subjects who successfully tried at least one study lens, based on treatment-specific exposure.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
AOAMV	0 of 25 (0%)	1 of 25 (4%)	Not reported
AOAMF	0 of 23 (0%)	1 of 23 (4.3%)	Not reported
Lotra B SVD	0 of 23 (0%)	2 of 23 (8.7%)	Not reported
Biofinity MF	0 of 21 (0%)	0 of 21 (0%)	Not reported
Habitual	0 of 27 (0%)	2 of 27 (7.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Presbyopia

Recruiting
Evaluation of Functional Superiority of the Morrow eProgressive
Presbyopia
Recruiting
Volumetric Visual Fields at Intermediate and Near Distances in Presbyopic Patients Using Occupational and General-Purpose Progressive Addition Lenses
Presbyopia
Recruiting
VisDura VisAbility™ Micro Insert System Pre-market Clinical Trial
Presbyopia
Active, not recruiting
Clinical Trial With Artiflex Presbyopic (Artiplus)
Presbyopia, Ametropia
Recruiting
Volumetric Visual Fields at Different Distances in Presbyopic Patients Using Occupational (PC-133 and PC-200) and General-Purpose Progressive Addition Lenses
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sr. Clinical Manager, Global Medical Affairs, Vision Care study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Lotrafilcon B MF, Lotrafilcon B MV and Lotrafilcon B SVD in people with Presbyopia, run by Alcon Research.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Driving Reaction Time to Hazards (as Measured by Time to Brake, in Seconds) (time frame: Week 2, each period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02189863.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2016.