Refractive ErrorNCT02402127

Lubricity Post-Wear - Competitive Lenses Pilot

A study testing Narafilcon A contact lenses, Stenfilcon A contact lenses and Somofilcon A 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 measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of 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?: Narafilcon A contact lenses, Stenfilcon A contact lenses and Somofilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: No sites listed yet
Study dates: May 2015to Jul 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 form.
Soft contact lens wearer (both eyes).
Willing to wear study lenses at least 16 waking hours and attend all study visits.
Other protocol-specified inclusion criteria may apply.

Who cannot join

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.
Use of artificial tears and rewetting drops during the study.
Monocular (only 1 eye with functional vision) or fit with only 1 lens.
History of herpetic keratitis, ocular surgery, or irregular cornea.
Pregnant.
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear

The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

Read the detailed description

In this 3-treatment, 3-period, 6-sequence crossover study, each participant will wear all 3 products in randomized order, 1 product at a time, with a washout period of up to 7 days between treatment periods. Lenses will be collected for ex-vivo lubricity analysis. The ex-vivo lubricity analysis will be conducted under a separate non-clinical protocol.

Conditions: Refractive Error
Being tested: Narafilcon A contact lenses, Stenfilcon A contact lenses, Somofilcon A contact lenses
Keywords: Contact lenses, Lubricity
Medical subject headings: Refractive Errors

What participants receive

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

Narafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® TruEye® (TruEye)
Silicone hydrogel contact lenses for daily disposable wear
Stenfilcon A contact lensesDevice
Also called MyDay™
Silicone hydrogel contact lenses for daily disposable wear
Somofilcon A contact lensesDevice
Also called clariti® 1day
Silicone hydrogel contact lenses for daily disposable wear

Study groups in NCT02402127
Study group	Role	What they receive
TruEye, MyDay, clariti 1day	Other	Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 1 day (16 hours). Receives: Device: Narafilcon A contact lenses; Device: Stenfilcon A contact lenses; Device: Somofilcon A contact lenses
TruEye, clariti 1day, MyDay	Other	Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). Receives: Device: Narafilcon A contact lenses; Device: Stenfilcon A contact lenses; Device: Somofilcon A contact lenses
MyDay, TruEye, clariti 1day	Other	Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). Receives: Device: Narafilcon A contact lenses; Device: Stenfilcon A contact lenses; Device: Somofilcon A contact lenses
MyDay, clariti 1day, TruEye	Other	Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). Receives: Device: Narafilcon A contact lenses; Device: Stenfilcon A contact lenses; Device: Somofilcon A contact lenses
Clariti 1day, TruEye, MyDay	Other	Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). Receives: Device: Narafilcon A contact lenses; Device: Stenfilcon A contact lenses; Device: Somofilcon A contact lenses
Clariti 1day, MyDay, TruEye	Other	Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours). Receives: Device: Narafilcon A contact lenses; Device: Stenfilcon A contact lenses; Device: Somofilcon A contact lenses

What is being measured

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

Average Coefficient of Friction of Worn Lenses at 16 Hours
Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.
Measured: Day 1, Hour 16, each product

Secondary outcomes (1)

Average Coefficient of Friction of Unworn Lenses
Unworn contact lenses were removed from the commercial packaging and the coefficient of friction of the unworn lenses was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity.
Measured: Day 1 (each product)

Timeline

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

May 2015Jul 2015

First posted30 Mar 2015 (estimated)
Study startMay 2015
Primary completionJul 2015
Study completionJul 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.
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: Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02402127
Sponsor's protocol ID: CLT567-P001
Status last verified: Jul 2016
First submitted: 25 Mar 2015
Last updated: 2 Sep 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

Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
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Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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RecruitingPhase 4
Arcuate Incisions With Light Adjustable Lens for Astigmatism Correction in Lens Surgery
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All Refractive Error trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Lubricity of Daily Disposable Silicone Hydrogel Contact Lenses After Wear
ClinicalTrials.gov ID: NCT02402127
Acronym / sponsor ID: CLT567-P001
Conditions: Refractive Error
Keywords: Contact lenses, Lubricity
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: Jul 2015 (actual)
Study completion: Jul 2015 (actual)
First posted: 30 Mar 2015 (estimated)
Results: Posted 2 Sep 2016

Clinical summary

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

The purpose of this study is to measure the coefficient of friction of three silicone hydrogel, daily disposable contact lenses after 16 hours of wear.

Detailed description

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 6

Arm	Type	Receives
TruEye, MyDay, clariti 1day	Other	Device: Narafilcon A contact lenses, Device: Stenfilcon A contact lenses, Device: Somofilcon A contact lensesNarafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 1 day (16 hours).
TruEye, clariti 1day, MyDay	Other	Device: Narafilcon A contact lenses, Device: Stenfilcon A contact lenses, Device: Somofilcon A contact lensesNarafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).
MyDay, TruEye, clariti 1day	Other	Device: Narafilcon A contact lenses, Device: Stenfilcon A contact lenses, Device: Somofilcon A contact lensesStenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).
MyDay, clariti 1day, TruEye	Other	Device: Narafilcon A contact lenses, Device: Stenfilcon A contact lenses, Device: Somofilcon A contact lensesStenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).
Clariti 1day, TruEye, MyDay	Other	Device: Narafilcon A contact lenses, Device: Stenfilcon A contact lenses, Device: Somofilcon A contact lensesSomofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).
Clariti 1day, MyDay, TruEye	Other	Device: Narafilcon A contact lenses, Device: Stenfilcon A contact lenses, Device: Somofilcon A contact lensesSomofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3. Each product worn bilaterally for 1 day (16 hours).

Who may qualify

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

Key inclusion criteria (4 listed)

Must sign an informed consent form.
Soft contact lens wearer (both eyes).
Willing to wear study lenses at least 16 waking hours and attend all study visits.
Other protocol-specified inclusion criteria may apply.

Key exclusion criteria (7 listed)

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.
Use of artificial tears and rewetting drops during the study.
Monocular (only 1 eye with functional vision) or fit with only 1 lens.
History of herpetic keratitis, ocular surgery, or irregular cornea.

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
Narafilcon A contact lensesAlso: 1-DAY ACUVUE® TruEye® (TruEye)Silicone hydrogel contact lenses for daily disposable wear	Device	Clariti 1day, MyDay, TruEye, Clariti 1day, TruEye, MyDay, MyDay, TruEye, clariti 1day, MyDay, clariti 1day, TruEye, TruEye, MyDay, clariti 1day, TruEye, clariti 1day, MyDay
Stenfilcon A contact lensesAlso: MyDay™Silicone hydrogel contact lenses for daily disposable wear	Device	Clariti 1day, MyDay, TruEye, Clariti 1day, TruEye, MyDay, MyDay, TruEye, clariti 1day, MyDay, clariti 1day, TruEye, TruEye, MyDay, clariti 1day, TruEye, clariti 1day, MyDay
Somofilcon A contact lensesAlso: clariti® 1daySilicone hydrogel contact lenses for daily disposable wear	Device	Clariti 1day, MyDay, TruEye, Clariti 1day, TruEye, MyDay, MyDay, TruEye, clariti 1day, MyDay, clariti 1day, TruEye, TruEye, MyDay, clariti 1day, TruEye, clariti 1day, MyDay

Primary outcome

Average Coefficient of Friction of Worn Lenses at 16 Hours
Time frame: Day 1, Hour 16, each product
Worn contact lenses were removed from the participant's eye and the coefficient of friction was measured by the inclined plane method. A lower coefficient of friction may indicate higher contact lens lubricity. The ex-vivo lubricity was carried out on one lens (one eye) only.

1 secondary outcome

Average Coefficient of Friction of Unworn Lenses
Time frame: Day 1 (each product)

Results and safety

Results posted to the registry on 2 Sep 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
TruEye, MyDay, Clariti 1day	4	4
TruEye, Clariti 1day, MyDay	4	4
MyDay, TruEye, Clariti 1day	4	4
MyDay, Clariti 1day, TruEye	4	4
Clariti 1day, TruEye, MyDay	4	4
Clariti 1day, MyDay, TruEye	4	4

Primary outcome: Average Coefficient of Friction of Worn Lenses at 16 Hours

Time frame: Day 1, Hour 16, each product. Mean (Standard Deviation). Unit: unitless

Measure	TruEye n = 18	MyDay n = 18	Clariti 1day n = 18
Value	0.0602 (0.00474)	0.0576 (0.00338)	0.0578 (0.00439)

Population analysed: Intention to treat participants with non-missing observations

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events (AEs) were collected for the duration of the study from the signing of informed consent (up to 17 days). This analysis population includes all participants exposed to investigational product.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
TruEye	0 of 24 (0%)	0 of 24 (0%)	Not reported
MyDay	0 of 24 (0%)	0 of 24 (0%)	Not reported
Clariti 1day	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

Not yet recruitingObservational study
Corneal Biomechanics and Stromal Tissue Characteristics in Patients Undergoing SMILE
Myopia
Recruiting
Clareon TruPlus Study
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Enrolling by invitation
Therapeutic Efficacy of Different Repeated Low-Intensity Red Light Devices and Different Usage Frequencies
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Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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RecruitingPhase 4
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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.

Clinical Manager, Vision Care, Global Medical Affairs study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Narafilcon A contact lenses, Stenfilcon A contact lenses and Somofilcon A 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 4 inclusion and 7 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 2 Sep 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 2 Sep 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?

Average Coefficient of Friction of Worn Lenses at 16 Hours (time frame: Day 1, Hour 16, 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 NCT02402127.

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 2 Sep 2016.