Refractive ErrorNCT01997216

Multifocal Lens Design Evaluation

A study testing Delefilcon A multifocal contact lens and Lotrafilcon B multifocal contact lens in people with Refractive Error and 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 purpose of this study was to compare binocular high contrast, high illumination (HC/HI) visual acuity at near (40 centimeters) of new multifocal contact lenses against AIR OPTIX® AQUA MULTIFOCAL contact lenses when worn for 9 hours. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error, Presbyopia
What is being tested?: Delefilcon A multifocal contact lens and Lotrafilcon B multifocal contact lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 42 participants
Where: No sites listed yet
Study dates: Oct 2012to Nov 2012
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Sign written Informed Consent document.
Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
Be presbyopic with a spectacle add ≥ 0.50 diopter.
Currently wearing soft contact lenses at least 5 days a week.
Other protocol-specified inclusion criteria may apply

Who cannot join

Eye injury or surgery within 12 weeks of enrollment in this trial.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in any clinical trial.
Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.
Binocular visual acuity worse than 20/25.
Corrected by monovision.
Other protocol-defined exclusion criteria may apply.

About this study

Official title: Multifocal Lens Design Evaluation (US)

Read the detailed description

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Conditions: Refractive Error, Presbyopia
Being tested: Delefilcon A multifocal contact lens, Lotrafilcon B multifocal contact lens
Keywords: contact lenses, multifocal
Medical subject headings: Refractive Errors, Presbyopia

What participants receive

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

Delefilcon A multifocal contact lensDevice
Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
Lotrafilcon B multifocal contact lensDevice
Also called AIR OPTIX® AQUA MULTIFOCAL, AOAMF
Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines

Study groups in NCT01997216
Study group	Role	What they receive
Delefilcon A MF, then AOAMF	Other	Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days. Receives: Device: Delefilcon A multifocal contact lens; Device: Lotrafilcon B multifocal contact lens
AOAMF, then Delefilcon A MF	Other	Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days. Receives: Device: Delefilcon A multifocal contact lens; Device: Lotrafilcon B multifocal contact lens

What is being measured

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

Mean Binocular HC/HI Visual Acuity at Near (40 cm)
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.
Measured: Up to Hour 9

Secondary outcomes (2)

Mean Binocular HC/HI Visual Acuity at Distance
The participant read a Snellen chart at a 20-foot equivalent distance with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal distance eyesight. A negative logMAR value denotes better visual acuity.
Measured: Up to Hour 9
Mean Monocular Over-refraction (OR) at Distance
OR is the amount of additional correction needed to improve visual acuity (VA). The OR at dispense was conducted with non-study product to determine lens power for the 9-hour wear. Dispensing of the study product (Pair 1 and Pair 2) was dependent upon lens power as determined by OR and resultant product availability. The OR at 9 hours was conducted with study product. All OR data is reported regardless whether study product was dispensed. Each eye contributed to the mean.
Measured: Up to Hour 9

Timeline

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

Oct 2012Nov 2012

First posted28 Nov 2013 (estimated)
Study startOct 2012
Primary completionNov 2012
Study completionNov 2012

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 Refractive ErrorStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01997216
Sponsor's protocol ID: C-12-036
Status last verified: Dec 2013
First submitted: 19 Nov 2013
Last updated: 4 Feb 2014
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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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multifocal Lens Design Evaluation (US)
ClinicalTrials.gov ID: NCT01997216
Acronym / sponsor ID: C-12-036
Conditions: Refractive Error, Presbyopia
Keywords: contact lenses, multifocal
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 28 Nov 2013 (estimated)
Results: Posted 4 Feb 2014

Clinical summary

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

Detailed description

Each participant was randomized to a specific sequence of lens wear, during which each lens type was worn bilaterally for 9 hours to compare performance characteristics.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Delefilcon A MF, then AOAMF	Other	Device: Delefilcon A multifocal contact lens, Device: Lotrafilcon B multifocal contact lensDelefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
AOAMF, then Delefilcon A MF	Other	Device: Delefilcon A multifocal contact lens, Device: Lotrafilcon B multifocal contact lensLotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Sign written Informed Consent document.
Have spectacles that provide acceptable vision and be willing to wear them if unable to wear the study lenses.
Be presbyopic with a spectacle add ≥ 0.50 diopter.
Currently wearing soft contact lenses at least 5 days a week.
Other protocol-specified inclusion criteria may apply

Key exclusion criteria (8 listed)

Eye injury or surgery within 12 weeks of enrollment in this trial.
Pre-existing ocular irritation that would preclude contact lens fitting.
Currently enrolled in any clinical trial.
Evidence of systemic or ocular abnormality, infection, or disease which is likely to affect successful wear of contact lenses (for at least 9 hours) or use of their accessory solutions as determined by the Investigator.
Any use of medications for which contact lens wear could be contraindicated as determined by the Investigator.

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
Delefilcon A multifocal contact lensInvestigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines	Device	AOAMF, then Delefilcon A MF, Delefilcon A MF, then AOAMF
Lotrafilcon B multifocal contact lensAlso: AIR OPTIX® AQUA MULTIFOCAL, AOAMFCommercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines	Device	AOAMF, then Delefilcon A MF, Delefilcon A MF, then AOAMF

Primary outcome

Mean Binocular HC/HI Visual Acuity at Near (40 cm)
Time frame: Up to Hour 9
The participant read a Snellen chart at 40 centimeters with both eyes together while wearing study lenses. The Snellen acuity was converted into logMAR units (logarithm of the minimum angle of resolution). A 20/20 Snellen acuity equates to a logMAR acuity of 0.0 and is considered normal near eyesight. A negative logMAR value denotes better visual acuity.

2 secondary outcomes

Mean Binocular HC/HI Visual Acuity at Distance
Time frame: Up to Hour 9
Mean Monocular Over-refraction (OR) at Distance
Time frame: Up to Hour 9

Results and safety

Results posted to the registry on 4 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Delefilcon A MF, Then AOAMF	18	18
AOAMF, Then Delefilcon A MF	21	21

Primary outcome: Mean Binocular HC/HI Visual Acuity at Near (40 cm)

Time frame: Up to Hour 9. Mean (Standard Deviation). Unit: logMAR

Measure	Delefilcon A MF n = 39	AOAMF n = 40
Dispense (Hour 0)	0.08 (0.10)	0.06 (0.09)
Hour 9	0.05 (0.08)	0.05 (0.10)

Population analysed: All enrolled participants exposed to study product. 1 participant was not exposed to Delefilcon A MF due to product unavailability.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (1 month). An Adverse Event (AE) was any untoward medical occurrence, unintended disease or injury, or untoward clinical sign whether or not related to the investigational medical device.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A MF	0 of 39 (0%)	0 of 39 (0%)	Not reported
AOAMF	0 of 40 (0%)	0 of 40 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
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RecruitingPhase 3
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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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.

Joachim Nick, Dipl.-Ing study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A multifocal contact lens and Lotrafilcon B multifocal contact lens in people with Refractive Error and 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 5 inclusion and 8 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 4 Feb 2014. 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 4 Feb 2014). 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?

Mean Binocular HC/HI Visual Acuity at Near (40 cm) (time frame: Up to Hour 9). 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 NCT01997216.

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 4 Feb 2014.