Refractive ErrorNCT02517567

DAILIES TOTAL1® - Comparative Assessment of Tear Film Evaporation

A study testing Delefilcon A contact lenses, Narafilcon 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 evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact 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?: Delefilcon A contact lenses, Narafilcon 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: 37 participants
Where: No sites listed yet
Study dates: 21 Sep 2015to 22 Apr 2016
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 an informed consent document;
Adapted, current soft contact lens wearer;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
Can be successfully fitted with study lenses;
Willing to wear lenses for a minimum of 8 hours prior to each study visit;
Willing to discontinue artificial tears and rewetting drops usage on the days of 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 as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only one lens;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Known pregnancy and lactation;
Other protocol-specified exclusion criteria may apply.

About this study

Official title: Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids

The purpose of this study is to evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Read the detailed description

This study consists of 5 visits (1 screening, 4 assessment) with a maximum of 6 days between assessment visits and at least 24 hours of no lens wear the day prior to the visit. Each subject will be randomized to a crossover sequence of 4 periods. Different study lenses will be worn during 3 of the periods, for at least 8 hours each, and the remaining period will have no lens wear.

Conditions: Refractive Error
Being tested: Delefilcon A contact lenses, Narafilcon A contact lenses, Somofilcon A contact lenses
Medical subject headings: Refractive Errors

What participants receive

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

Delefilcon A contact lensesDevice
Also called DAILIES TOTAL1®
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Narafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® TruEye®
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
Somofilcon A contact lensesDevice
Also called clariti® 1 day
Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions

Study groups in NCT02517567
Study group	Role	What they receive
Sequence 1	Other	Delefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses
Sequence 2	Other	Narafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses
Sequence 3	Other	Somofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses; Device: Somofilcon A contact lenses
Sequence 4	Other	No lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon 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.

Tear Film Evaporation Rate
Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.
Measured: Day 1, 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.

21 Sep 201522 Apr 2016

First posted7 Aug 2015 (estimated)
Study start21 Sep 2015
Primary completion22 Apr 2016
Study completion22 Apr 2016

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: Single blind
Who is masked: Investigator
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02517567
Sponsor's protocol ID: CLT978-P001
Status last verified: Jul 2017
First submitted: 5 Aug 2015
Last updated: 2 Jul 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: 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 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study on the Effect of Daily Disposable Silicone Hydrogel Contact Lenses on Tear Film Lipids
ClinicalTrials.gov ID: NCT02517567
Acronym / sponsor ID: CLT978-P001
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 21 Sep 2015 (actual)
Primary completion: 22 Apr 2016 (actual)
Study completion: 22 Apr 2016 (actual)
First posted: 7 Aug 2015 (estimated)
Results: Posted 1 Feb 2018

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 evaluate the tear film evaporation of symptomatic soft contact lens wearers in the absence of contact lens wear and after at least 8 hours of contact lens wear.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Sequence 1	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lenses, Device: Somofilcon A contact lensesDelefilcon A, then narafilcon A, then somofilcon A, then no lens wear. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Sequence 2	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lenses, Device: Somofilcon A contact lensesNarafilcon A, then no lens wear, then delefilcon A, then somofilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Sequence 3	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lenses, Device: Somofilcon A contact lensesSomofilcon A, then delefilcon A, then no lens wear, then narafilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.
Sequence 4	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lenses, Device: Somofilcon A contact lensesNo lens wear, then somofilcon A, then narafilcon A, then delefilcon A. Each contact lens product was worn for 8 hours. The 'No Lens wear' treatment was evaluated over an 8 hour period.

Who may qualify

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

Key inclusion criteria (7 listed)

Sign an informed consent document;
Adapted, current soft contact lens wearer;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
Can be successfully fitted with study lenses;
Willing to wear lenses for a minimum of 8 hours prior to each study visit;

Key exclusion criteria (6 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 as determined by the investigator;
Monocular (only 1 eye with functional vision) or fit with only one lens;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Known pregnancy and lactation;

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 contact lensesAlso: DAILIES TOTAL1®Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions	Device	Sequence 1, Sequence 2, Sequence 3, Sequence 4
Narafilcon A contact lensesAlso: 1-DAY ACUVUE® TruEye®Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions	Device	Sequence 1, Sequence 2, Sequence 3, Sequence 4
Somofilcon A contact lensesAlso: clariti® 1 dayDaily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions	Device	Sequence 1, Sequence 2, Sequence 3, Sequence 4

Primary outcome

Tear Film Evaporation Rate
Time frame: Day 1, Hour 8, each product
Tear film evaporation rate (amount of tears (grams or g) that evaporates over a surface area (m2) per hour (h)) assessment was performed using the VapoMeter as a non-invasive measurement of tear film evaporation over 10 seconds. Measurements were taken on both the right and left eyes after 8 hours of lens wear or no lens wear, as applicable. A higher evaporation rate can be a contributing factor to eye irritation and lens intolerance.

Results and safety

Results posted to the registry on 1 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	6	6
Sequence 2	8	8
Sequence 3	7	7
Sequence 4	8	8

Primary outcome: Tear Film Evaporation Rate

Time frame: Day 1, Hour 8, each product. Mean (Standard Deviation). Unit: gm^-2 h

Measure	Lens n = 29	No Lens n = 29
Value	120.88 (45.563)	105.63 (53.361)

Population analysed: This analysis population includes all randomized subjects (Intent-to-Treat). To address the primary objective of comparing Lens vs. No Lens, results from all 3 study lenses are combined. Therefore, subjects (eyes) are counted multiple times in Lens group due to crossover design and number of eyes with non-missing response is reported.

Adverse events

Time frame: Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 5 weeks). AEs are reported as pretreatment and treatment-emergent.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pretreatment	0 of 37 (0%)	0 of 37 (0%)	0 of 37
DAILIES TOTAL1	0 of 29 (0%)	0 of 29 (0%)	0 of 29
TruEye	0 of 28 (0%)	0 of 28 (0%)	0 of 28
Clariti	0 of 29 (0%)	0 of 29 (0%)	0 of 29
No Lens	0 of 29 (0%)	0 of 29 (0%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Refractive Error

Recruiting
Managing Premyopia in Chinese Children Using Artificial Intelligence Assisted Defocus Incorporated Multiple Segments Based Spectacle Lens: a Randomized Controlled Clinical Trial
Pre-myopia, Myopia
Not yet recruiting
BRIGHT-LIGHT: Studying Red Light Therapy for Severe Short-Sightedness or Short-Sightedness That Worsens Despite Standard Treatment
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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RecruitingPhase 1/2
Psilocybin for Amblyopia - Targeting Critical Periods in Humans
Amblyopia
Recruiting
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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, Clinical Trial Management study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A contact lenses, Narafilcon 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 7 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 2 Jul 2018. 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 1 Feb 2018). 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?

Tear Film Evaporation Rate (time frame: Day 1, Hour 8, 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 NCT02517567.

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 Jul 2018.