Refractive ErrorNCT02710292

Clinical Evaluation of DAILIES TOTAL 1® Performance in a Japanese Population

A study testing Delefilcon A contact lenses and Narafilcon A contact lenses in people with Refractive Error, run by Alcon Research at 1 site in Japan.

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 compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Refractive Error
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: 104 participants
Where: 1 siteJapan
Study dates: 25 Apr 2016to 14 Sep 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 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Must sign an informed consent form;
Habitual current daily disposable soft contact lenses wearer;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
Lenses within the power range specified in the protocol;
Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;
Acceptable lens fit with both study contact lenses;
Willing to wear lenses every day or at least for a minimum of 10 days, 6 hours per day, every day if possible and attend all study visits;
Other protocol-specified inclusion criteria may apply.

Who cannot join

Currently wearing DT1 or TE sphere lenses;
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
Eye injury or surgery within 12 weeks immediately prior to enrollment;
History of herpetic keratitis, ocular surgery or irregular cornea;
Prior refractive surgery;

Show all 9Show fewer

Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Participation in any clinical trial within 30 days of the enrollment visit;
Other protocol-specified exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Contact Alcon Japan, Ltd. for Trial Locations
Tokyo, 107-0052

Other trials in Japan

About this study

Official title: Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®

The purpose of this study is to compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Conditions: Refractive Error
Being tested: Delefilcon A contact lenses, Narafilcon 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 TOTAL 1®, DT1
Narafilcon A contact lensesDevice
Also called 1-DAY ACUVUE® TruEye®

Study groups in NCT02710292
Study group	Role	What they receive
DT1, then TE	Other	Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality. Receives: Device: Delefilcon A contact lenses; Device: Narafilcon A contact lenses
TE, then DT1	Other	Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality. 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.

Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.
Measured: Day 10, each product

Timeline

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

25 Apr 201614 Sep 2016

First posted16 Mar 2016 (estimated)
Study start25 Apr 2016
Primary completion14 Sep 2016
Study completion14 Sep 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: Participant
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02710292
Sponsor's protocol ID: CLS104-P001
Status last verified: May 2017
First submitted: 11 Mar 2016
Last updated: 2 Jul 2018
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

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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: Clinical Evaluation of DAILIES TOTAL 1® in Japanese Population - Comparison of Lens Centration Between DAILIES TOTAL 1® and 1-DAY ACUVUE® TruEye®
ClinicalTrials.gov ID: NCT02710292
Acronym / sponsor ID: CLS104-P001
Conditions: Refractive Error
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Alcon ResearchIndustry (pharma, biotech, devices)
Study start: 25 Apr 2016 (actual)
Primary completion: 14 Sep 2016 (actual)
Study completion: 14 Sep 2016 (actual)
First posted: 16 Mar 2016 (estimated)
Results: Posted 3 Oct 2017

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 compare DAILIES TOTAL1® (DT1) to 1-DAY ACUVUE® TruEye® (TE) for Investigator-rated successful lens centration in Japanese population.

Study design

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

Arm	Type	Receives
DT1, then TE	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lensesDelefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.
TE, then DT1	Other	Device: Delefilcon A contact lenses, Device: Narafilcon A contact lensesNarafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product will be worn bilaterally (in both eyes) for at least 7 days in a daily disposable modality.

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Must sign an informed consent form;
Habitual current daily disposable soft contact lenses wearer;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Questionnaire;
Lenses within the power range specified in the protocol;
Vision correctable to 20/25 or 0.1 logMAR (logarithmic minimum angle of resolution) or better in each eye at distance with pre-study contact lenses at Visit1;

Key exclusion criteria (9 listed)

Currently wearing DT1 or TE sphere lenses;
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
Use of systemic or ocular medications in which contact lens wear could be contraindicated as determined by the investigator;
Eye injury or surgery within 12 weeks immediately prior to enrollment;
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
Delefilcon A contact lensesAlso: DAILIES TOTAL 1®, DT1	Device	DT1, then TE, TE, then DT1
Narafilcon A contact lensesAlso: 1-DAY ACUVUE® TruEye®	Device	DT1, then TE, TE, then DT1

Primary outcome

Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear
Time frame: Day 10, each product
Lens centration was assessed by the investigator on a 5-point scale, where 0=Optimal and 4=Severe decentration (with corneal exposure). Both eyes contributed to the analysis.

Results and safety

Results posted to the registry on 3 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DT1, Then TE	47	46
TE, Then DT1	52	49

Primary outcome: Percentage of Subjects With Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear

Time frame: Day 10, each product. Number. Unit: percentage of subjects

Measure	Dailies Total1 n = 95	TruEye n = 97
Value	89.5	47.4

Population analysed: This analysis population includes all subjects who used the study device and in whom data after the use of the study device were available (Full Analysis Set).

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 26 days). 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 104 (0%)	0 of 104 (0%)	Not reported
Dailies Total1	0 of 96 (0%)	7 of 96 (7.3%)	Not reported
TruEye	0 of 98 (0%)	23 of 98 (23.5%)	Not reported

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.

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RecruitingPhase 1/2
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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 Development study director

Alcon Japan, Ltd.

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 Refractive Error, run by Alcon Research at 1 site in Japan.

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 9 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.

Where is the study taking place?

The record lists 1 site in Japan. 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 3 Oct 2017). 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 Investigator-rated Lens Centration of "Optimal" After 10 Days of Wear (time frame: Day 10, 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 NCT02710292.

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.