Refractive ErrorNCT02289742

Tear Film Evaluation of Dailies® AquaComfort Plus® Multifocal and Toric

A study testing Nelfilcon A multifocal contact lenses, Nelfilcon A toric contact lenses and Nelfilcon A sphere contact lenses in people with Refractive Error, 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 is to evaluate the pre lens tear film characteristics of DAILIES® Aqua Comfort Plus® Multifocal (DACP MF) and Toric (DACP Toric) compared to DAILIES® Aqua Comfort Plus® Sphere (DACP) daily disposable contact lenses over 12 hours of lens wear. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Refractive Error
What is being tested?: Nelfilcon A multifocal contact lenses, Nelfilcon A toric contact lenses and Nelfilcon A sphere contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 48 participants
Where: No sites listed yet
Study dates: Dec 2014to Mar 2015
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

Must sign an informed consent document;
Adapted, current soft contact lens wearer with either:
A spectacle add between +0.50 and +2.50 (inclusive) [Presbyopes group]
A spherical correction of an astigmatism up to 20% of the amount of the sphere [Astigmats group];
Contact lens prescription in the power range specified in the protocol;
Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;

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Willing to wear study lenses up to 12 hours and attend all study visits;
Can be successfully fitted with study lenses;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Use of artificial tears and rewetting drops during the study;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;
History of herpetic keratitis, ocular surgery, or irregular cornea;

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Pregnant or lactating;
Unstable tear film with a NIK-BUT value below 8 seconds in either eye without lenses;
Participation in any clinical study within 30 days of Visit 1;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection

Read the detailed description

Two population groups (presbyopes and astigmats) will be enrolled in the study.

Conditions: Refractive Error
Being tested: Nelfilcon A multifocal contact lenses, Nelfilcon A toric contact lenses, Nelfilcon A sphere contact lenses
Keywords: Dailies AquaComfort Plus® Multifocal (DACP MF), Dailies AquaComfort Plus® Toric (DACP Toric), tear film stability, Non-Invasive Keratograph Break-Up Time (NIK-BUT)
Medical subject headings: Refractive Errors

What participants receive

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

Nelfilcon A multifocal contact lensesDevice
Also called DAILIES® AquaComfort Plus® Multifocal, DACP MF
Nelfilcon A toric contact lensesDevice
Also called DAILIES® AquaComfort Plus® Toric, DACP Toric
Nelfilcon A sphere contact lensesDevice
Also called DAILIES® AquaComfort Plus®, DACP

Study groups in NCT02289742
Study group	Role	What they receive
Arm1: Presbyopes	Other	Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. Receives: Device: Nelfilcon A multifocal contact lenses; Device: Nelfilcon A sphere contact lenses
Arm2: Astigmats	Other	Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours. Receives: Device: Nelfilcon A toric contact lenses; Device: Nelfilcon A sphere contact lenses

What is being measured

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

Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Measured: Hour 12, each product

Secondary outcomes (1)

Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.
Measured: Hour 8, each product

Timeline

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

Dec 2014Mar 2015

First posted13 Nov 2014 (estimated)
Study startDec 2014
Primary completionMar 2015
Study completionMar 2015

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.
More trials run by Alcon ResearchThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 48 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02289742
Sponsor's protocol ID: M-14-010
Status last verified: Jun 2016
First submitted: 10 Nov 2014
Last updated: 26 Jul 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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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Characterization of Pre-Lens Tear Film Stability of Daily Disposable Multifocal and Toric Contact Lenses Using Ring Mire Projection
ClinicalTrials.gov ID: NCT02289742
Acronym / sponsor ID: M-14-010
Conditions: Refractive Error
Keywords: Dailies AquaComfort Plus® Multifocal (DACP MF), Dailies AquaComfort Plus® Toric (DACP Toric), tear film stability, Non-Invasive Keratograph Break-Up Time (NIK-BUT)
Study type: Interventional
Recruitment status: Completed
Enrolment: 48 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 13 Nov 2014 (estimated)
Results: Posted 26 Jul 2016

Clinical summary

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

Detailed description

Two population groups (presbyopes and astigmats) will be enrolled in the study.

Study design

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

Arm	Type	Receives
Arm1: Presbyopes	Other	Device: Nelfilcon A multifocal contact lenses, Device: Nelfilcon A sphere contact lensesNelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
Arm2: Astigmats	Other	Device: Nelfilcon A toric contact lenses, Device: Nelfilcon A sphere contact lensesNelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.

Who may qualify

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

Key inclusion criteria (9 listed)

Must sign an informed consent document;
Adapted, current soft contact lens wearer with either:
Contact lens prescription in the power range specified in the protocol;
Vision correctable to 0.2 logMAR (logarithmic minimal angle for resolution) or better in each eye at distance with pre-study lenses or manifest refraction at Visit 1;
Willing to wear study lenses up to 12 hours and attend all study visits;

Key exclusion criteria (10 listed)

Any ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
Use of artificial tears and rewetting drops during the study;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Any abnormal ocular condition observed during the Visit 1 slit-lamp examination;

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
Nelfilcon A multifocal contact lensesAlso: DAILIES® AquaComfort Plus® Multifocal, DACP MF	Device	Arm1: Presbyopes
Nelfilcon A toric contact lensesAlso: DAILIES® AquaComfort Plus® Toric, DACP Toric	Device	Arm2: Astigmats
Nelfilcon A sphere contact lensesAlso: DAILIES® AquaComfort Plus®, DACP	Device	Arm1: Presbyopes, Arm2: Astigmats

Primary outcome

Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear
Time frame: Hour 12, each product
A video was made to capture a visual demonstration of tear film characteristics in between blinks. The investigator graded contact lens surface wettability using a scale from 0 (fully wettable) to 3 (clearly visible distortions) at 5, 10, 15, 20 and 25 seconds post-blink by region (central, superior, nasal, inferior, and temporal). Three independent measurements (3 blinks) were carried out. An average was taken over the 3 measurements, 5 regions, and 5 time points. One eye contributed to the analysis.

1 secondary outcome

Percentage of Subjects With Wettability Grade of 2 or 3 After 8 Hours of Wear
Time frame: Hour 8, each product

Results and safety

Results posted to the registry on 26 Jul 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
Presbyopes MF/Sphere	11	11
Presbyopes Sphere/MF	12	11
Astigmats Toric/Sphere	12	11
Astigmats Sphere/Toric	10	9

Primary outcome: Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear

Time frame: Hour 12, each product. Number. Unit: percentage of subjects

Measure	Presbyopes / Multifocal n = 22	Presbyopes / Sphere n = 22	Astigmats / Toric n = 21	Astigmats / Sphere n = 20
Value	55.8	47.2	46.5	49.5

Population analysed: This analysis population includes all randomized and exposed subjects with data at visit.

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 24 days). Ocular adverse events are presented for both study eye and non-study eye combined. AEs were reported as pre-treatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-treatment	0 of 48 (0%)	0 of 48 (0%)	Not reported
Presbyopes / Multifocal	0 of 22 (0%)	0 of 22 (0%)	Not reported
Presbyopes / Sphere First Exposure	0 of 22 (0%)	0 of 22 (0%)	Not reported
Presbyopes / Sphere Second Exposure	0 of 22 (0%)	0 of 22 (0%)	Not reported
Astigmats / Toric	0 of 21 (0%)	0 of 21 (0%)	Not reported
Astigmats / Sphere First Exposure	0 of 20 (0%)	0 of 20 (0%)	Not reported
Astigmats / Sphere Second Exposure	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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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 Med Affairs, Operations study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Nelfilcon A multifocal contact lenses, Nelfilcon A toric contact lenses and Nelfilcon A sphere contact lenses in people with Refractive Error, 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 9 inclusion and 10 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 26 Jul 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 26 Jul 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?

Percentage of Subjects With Wettability Grade of 2 or 3 After 12 Hours of Wear (time frame: Hour 12, each product). 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 NCT02289742.

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 26 Jul 2016.