MyopiaNCT01561560

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

A study testing Delefilcon A contact lenses and Narafilcon A contact lenses in people with Myopia, run by Alcon Research at 1 site in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Myopia
What is being tested?: Delefilcon A contact lenses and Narafilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 123 participants
Where: 1 siteUnited States
Study dates: May 2012to Aug 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.
Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
Willing to wear study lenses for at least eight hours per day and at least five days per week.
Other protocol-defined inclusion criteria may apply.

Who cannot join

Has not worn contact lenses before.
Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
Ocular surgery/trauma within the last six months.
Topical ocular or systemic use of antibiotics within seven days of enrollment.
Pregnant or nursing women.
Other protocol-defined exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

United States1 site

Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134

Other trials in United States

About this study

The purpose of this crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Conditions: Myopia
Being tested: Delefilcon A contact lenses, Narafilcon A contact lenses
Keywords: DAILIES TOTAL1, contact lenses, myopia
Medical subject headings: Myopia

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®
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
Narafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® TRUEYE™
CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two

Study groups in NCT01561560
Study group	Role	What they receive
DAILIES TOTAL1, then TRUEYE	Other	Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses
TRUEYE, then DAILIES TOTAL1	Other	Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses

What is being measured

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

End-of-day Comfort
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).
Measured: Week 2

Timeline

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

May 2012Aug 2012

First posted23 Mar 2012 (estimated)
Study startMay 2012
Primary completionAug 2012
Study completionAug 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 MyopiaStudies 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: None (open label)
Enrolment: 123 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01561560
Sponsor's protocol ID: P-347-C-019
Status last verified: Nov 2013
First submitted: 21 Mar 2012
Last updated: 7 Jan 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?

See locations

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
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses
ClinicalTrials.gov ID: NCT01561560
Acronym / sponsor ID: P-347-C-019
Conditions: Myopia
Keywords: DAILIES TOTAL1, contact lenses, myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 123 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Aug 2012 (actual)
Study completion: Aug 2012 (actual)
First posted: 23 Mar 2012 (estimated)
Results: Posted 7 Jan 2014

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 crossover study was to evaluate the end-of-day comfort of two commercially available, daily disposable, silicone hydrogel contact lenses.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DAILIES TOTAL1, then TRUEYE	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lensesDelefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
TRUEYE, then DAILIES TOTAL1	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lensesNarafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.

Who may qualify

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

Key inclusion criteria (6 listed)

Sign written Informed Consent Document.
Currently wearing soft contact lenses in both eyes and identified as symptomatic based on questionnaire responses.
Currently wearing either daily disposable contact lenses or weekly/monthly replacement contact lenses.
Able to achieve visual acuity of at least 6/7.5 in each eye with study lenses in the available parameters.
Willing to wear study lenses for at least eight hours per day and at least five days per week.

Key exclusion criteria (7 listed)

Has not worn contact lenses before.
Currently wearing DAILIES TOTAL1 or 1-DAY ACUVUE TRUEYE contact lenses.
Any systemic or ocular disease or disorder that would negatively affect the conduct or outcome of the study.
Ocular surgery/trauma within the last six months.
Topical ocular or systemic use of antibiotics within seven days of enrollment.

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®CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two	Device	DAILIES TOTAL1, then TRUEYE, TRUEYE, then DAILIES TOTAL1
Narafilcon A contact lensesAlso: 1-DAY ACUVUE® TRUEYE™CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two	Device	DAILIES TOTAL1, then TRUEYE, TRUEYE, then DAILIES TOTAL1

Primary outcome

End-of-day Comfort
Time frame: Week 2
End-of-day comfort was interpreted and reported by the participant on a questionnaire as a single, retrospective measurement of two weeks of wear. Participants were asked, "Please rate the study lenses you have been wearing the in the following area: End-of-day comfort" and recorded their response on a continuous 1-10 Likert scale (1=poor and 10=excellent).

Results and safety

Results posted to the registry on 7 Jan 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
DAILIES TOTAL1, Then TRUEYE	60	60
TRUEYE, Then DAILIES TOTAL1	61	59

Primary outcome: End-of-day Comfort

Time frame: Week 2. Mean (Standard Deviation). Unit: Units on a scale

Measure	DAILIES TOTAL1 n = 116	TRUEYE n = 116
Value	8.3 (1.91)	6.6 (2.22)

Population analysed: This reporting group includes all participants who finished the study, minus any major protocol deviations as determined by masked review.

Adverse events

Time frame: Adverse events were collected for the duration of the study. The safety population includes all participants enrolled and exposed to Test Article.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DAILIES TOTAL1	0 of 119 (0%)	0 of 119 (0%)	Not reported
TRUEYE	0 of 121 (0%)	0 of 121 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Myopia

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
Astigmatism
Active, not recruiting
Effect of IOP Lowering on Progressive HM
High Myopia, Intraocular Pressure
Recruiting
Evaluation of a New Laser Refractive Vision Correction Using the TENEO™ 317 Model 2
Hyperopia and Myopia

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.

Camille Girault study director

Alcon Research

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A contact lenses and Narafilcon A contact lenses in people with Myopia, run by Alcon Research at 1 site in United States.

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 6 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 7 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 7 Jan 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?

End-of-day Comfort (time frame: Week 2). 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 NCT01561560.

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 7 Jan 2014.