MyopiaNCT01634659

Clinical Evaluation of Two Daily Disposable Silicone Hydrogel Contact Lenses

A study testing Delefilcon A contact lenses (DAILIES TOTAL1®) and Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) in people with Myopia, 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 the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable 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 (DAILIES TOTAL1®) and Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 330 participants
Where: No sites listed yet
Study dates: Jul 2012to Sep 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 and HIPAA form.
Be current weekly/monthly replacement contact lens wearer.
Be willing to not sleep in contact lenses during the study period.
Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
Have best corrected visual acuity of at least 20/25 in each eye.
Be willing to wear study lenses for at least 8 hours/day and at least 5 days/week.
Use re-wetting drops less than once per day and be willing to discontinue use of rewetting drops while wearing the study contact lenses.
Other protocol-specified inclusion criteria may apply.

Who cannot join

Be a neophyte or current wearer of daily disposable lenses.
Require monovision correction or use multifocal contact lenses.
Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
Have a history of ocular surgery/trauma within the last 6 months.
Use topical ocular or systemic antibiotics within 7 days of enrollment.
Use topical ocular or systemic corticosteroids within 14 days of enrollment, continuing throughout the study.

Show all 10Show fewer

Have participated in any other ophthalmic drug or device clinical trial within 30 days of enrollment.
Have habitually worn contact lenses on an extended wear basis (sleeping in habitual contact lenses for at least 2 nights per week) in the last 3 months prior to enrollment.
Use re-wetting drops once or more per day.
Other protocol-defined exclusion criteria may apply.

About this study

The purpose of this study was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

Conditions: Myopia
Being tested: Delefilcon A contact lenses (DAILIES TOTAL1®), Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Keywords: 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 lenses (DAILIES TOTAL1®)Device
Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)Device
Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use

Study groups in NCT01634659
Study group	Role	What they receive
Delefilcon A, then narafilcon B	Other	Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. Receives: Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)
Narafilcon B, then delefilcon A	Other	Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days. Receives: Device: Delefilcon A contact lenses (DAILIES TOTAL1®); Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)

What is being measured

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

Overall Comfort
Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Measured: Day 8

Secondary outcomes (2)

Overall Quality of Vision
Overall quality of vision was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall quality of vision was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Measured: Day 8
End of Day Comfort
End of day comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. End of day comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.
Measured: Day 8

Timeline

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

Jul 2012Sep 2012

First posted6 Jul 2012 (estimated)
Study startJul 2012
Primary completionSep 2012
Study completionSep 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: Single blind
Who is masked: Participant
Enrolment: 330 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01634659
Sponsor's protocol ID: M-12-033
Status last verified: Nov 2013
First submitted: 3 Jul 2012
Last updated: 24 Dec 2013
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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Study at a glance

From the registry record, last updated by the sponsor on 24 Dec 2013. 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: NCT01634659
Acronym / sponsor ID: M-12-033
Conditions: Myopia
Keywords: contact lenses, myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 330 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: Jul 2012
Primary completion: Sep 2012 (actual)
Study completion: Sep 2012 (actual)
First posted: 6 Jul 2012 (estimated)
Results: Posted 28 Nov 2013

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 was to compare the subjective performance of DAILIES TOTAL1® daily disposable contact lenses to that of 1-DAY ACUVUE® TruEye® daily disposable contact lenses.

Study design

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

Arm	Type	Receives
Delefilcon A, then narafilcon B	Other	Device: Delefilcon A contact lenses (DAILIES TOTAL1®), Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
Narafilcon B, then delefilcon A	Other	Device: Delefilcon A contact lenses (DAILIES TOTAL1®), Device: Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.

Who may qualify

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

Key inclusion criteria (8 listed)

Sign written Informed Consent Document and HIPAA form.
Be current weekly/monthly replacement contact lens wearer.
Be willing to not sleep in contact lenses during the study period.
Require vision correction in both eyes, with a contact lens prescription in protocol-specified power range.
Have best corrected visual acuity of at least 20/25 in each eye.

Key exclusion criteria (10 listed)

Be a neophyte or current wearer of daily disposable lenses.
Require monovision correction or use multifocal contact lenses.
Have any systemic or ocular disease or disorder, complicating factor, or structural abnormality that would negatively affect the conduct or outcome of the study.
Have a history of ocular surgery/trauma within the last 6 months.
Use topical ocular or systemic antibiotics within 7 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 lenses (DAILIES TOTAL1®)Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use	Device	Delefilcon A, then narafilcon B, Narafilcon B, then delefilcon A
Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use	Device	Delefilcon A, then narafilcon B, Narafilcon B, then delefilcon A

Primary outcome

Overall Comfort
Time frame: Day 8
Overall comfort was interpreted by the participant and recorded on a questionnaire as a single, retrospective evaluation of 8 days of wear. Overall comfort was evaluated binocularly and rated on a 10-point scale, with 1 being poor and 10 being excellent. Both eyes contributed to the mean.

2 secondary outcomes

Overall Quality of Vision
Time frame: Day 8
End of Day Comfort
Time frame: Day 8

Results and safety

Results posted to the registry on 28 Nov 2013, 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, Then Narafilcon B	155	155
Narafilcon B, Then Delefilcon A	158	158

Primary outcome: Overall Comfort

Time frame: Day 8. Mean (Standard Deviation). Unit: Units on a scale

Measure	Delefilcon A n = 301	Narafilcon B n = 301
Value	8.5 (1.7)	8.6 (1.5)

Population analysed: Per-Protocol: All participants completing the study and satisfying all of the inclusion/exclusion criteria, minus protocol deviations as determined by masked review.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected for the duration of the study (3 months).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Delefilcon A	0 of 313 (0%)	0 of 313 (0%)	Not reported
Narafilcon B	0 of 313 (0%)	0 of 313 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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
Myopia, Myopia Progressing
Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
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Active, not recruiting
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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.

Jami Kern, MBA, PhD study director

Alcon Research

Questions about this trial

What is this clinical trial studying?

A study testing Delefilcon A contact lenses (DAILIES TOTAL1®) and Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) in people with Myopia, 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 8 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 24 Dec 2013. 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 28 Nov 2013). 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?

Overall Comfort (time frame: Day 8). 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 NCT01634659.

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 24 Dec 2013.