CompletedNCT02252133Updated Jan 29, 2016Results posted

DAILIES TOTAL1® Lens Centration in a Japanese Population

An interventional study of Delefilcon A contact lenses and Narafilcon A contact lenses in Myopia and Refractive Error, sponsored by Alcon Research. Completed at 1 site in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by Alcon Research (part of Alcon) · Not applicable and Interventional

Phase: Not applicable
Study type: Interventional
Enrollment: 53
Allocation: Randomized
Ages: 20 Years and older
Sex: All

Study summary

The purpose of this study is to compare the lens centration of DAILIES TOTAL1® (DT1) contact lenses to 1-DAY ACUVUE® Tru-Eye® (1DAVTE) contact lenses in a Japanese population after 7 ± 2 days of wearing of each product.

Conditions studied

Myopia
Refractive Error

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Keywords

Contact lenses
Myopia

In context

Myopia

1,007 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 53 is below the median of 80 across 803 interventional studies indexed under Myopia.

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Lead sponsor

Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.

Of its 111 completed or terminated interventional studies of FDA-regulated products, 100 (90%) have results posted.

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Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Sign Informed Consent document.
Habitually wear soft contact lenses on a daily disposable or weekly/monthly replacement basis.
Symptoms of contact lens discomfort as defined by protocol.
Require contact lenses within the power range of -0.50 diopter (D) to -10.00 D.
Cylinder, if present, less or equal to 0.75D in either eyes at Visit 1.
Vision correctable to 20/25 or 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
Acceptable contact lens fit with both study contact lenses.
Willing to wear lenses every day for at least for a minimum of five days per week six hours per day, every day if possible and attend all study visits.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

Currently wearing DT1 or 1DAVTE.
Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
Use of systemic or ocular medications which contact lens wear could be contraindicated as determined by the investigator.
Eye injury or surgery within twelve weeks immediately prior to enrollment for this trial.
Any moderate or severe ocular condition observed during the slit-lamp examination at the enrollment visit.
History of herpetic keratitis, ocular surgery or irregular cornea.
Prior refractive surgery (e.g. LASIK, PRK, etc).
Monocular subjects (only one eye with functional vision) or subjects fit with only one lens.
Judged ineligible as a patient in this clinical study by the investigator.
Other protocol-defined exclusion criteria may apply.

Study design

Phase: Not applicable
Allocation: Randomized
Intervention model: Crossover assignment
Masking: None (open label)
Enrollment: 53 participants (actual)

Study arms

Other
DT1, then 1DAVTE
Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
Device: Delefilcon A contact lenses · Device: Narafilcon A contact lenses
Other
1DAVTE, then DT1
Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
Device: Delefilcon A contact lenses · Device: Narafilcon A contact lenses

Interventions

DeviceDelefilcon A contact lenses
Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear
Also known as: DAILIES TOTAL1®
DeviceNarafilcon A contact lenses
Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear
Also known as: 1-DAY ACUVUE® TruEye®

What researchers measure

Primary outcomes

Success Rate of Lens Centration After 7 ± 2 Days of Wear
Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.
Time frame: Day 7, each product

Results

Posted Dec 28, 2015

Participant flow

Subjects were recruited from 3 study centers located in Japan.

Period 1

Participant flow — Period 1
Milestone	DT1, Then 1DAVTE	1DAVTE, Then DT1
Started	23	24
Completed	23	24
Not completed	0	0

Period 2

Participant flow — Period 2
Milestone	DT1, Then 1DAVTE	1DAVTE, Then DT1
Started	23	24
Completed	23	24
Not completed	0	0

Outcome measures

PrimarySuccess Rate of Lens Centration After 7 ± 2 Days of Wear

Lens centration (the centration of the contact lens over the cornea) was rated by the investigator during slit lamp examination using a 5-point scale (0=optimal, 4=severe decentration). Success was defined as the percentage of subjects whose lens centration was rated as "optimal" or "slight decentration. One eye (study eye) was analyzed.

Time frame:: Day 7, each product
Reported as:: Number · percentage of subjects

Success Rate of Lens Centration After 7 ± 2 Days of Wear
percentage of subjects	Dailies Total 1	1DAVTE
Success Rate of Lens Centration After 7 ± 2 Days of Wear	100.0	86.7

Adverse events

Collected over Adverse events (AEs) were collected for the duration of a subject's participation in the study (up to 14 days). AEs were obtained through use of a subjective questionnaire.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Dailies Total 1	—	0/47 (0%)	0/47 (0%)
1DAVTE	—	0/47 (0%)	0/47 (0%)

Baseline characteristics

This analysis group includes all randomized subjects.

Age, Continuous
Age, Continuous(years)	Overall
Mean	37.0 ± 9.6

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	37
Male	10

Study locations

1 site

Contact Alcon Japan Ltd. for Trial Locations
Tokyo, Japan

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Nov 2014 and a completion of Nov 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2015, 1 year 1 month after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 26, 2014
First posted: Sep 30, 2014
Start: Oct 2014
Primary completionActual: Nov 2014
CompletionActual: Nov 2014
Results first posted: Dec 28, 2015
Last update: Jan 29, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02252133
Lead sponsor: Alcon Research
Responsible party: Sponsor
First posted: Sep 30, 2014
Start date: Oct 2014
Primary completion: Nov 2014
Completion: Nov 2014
Results posted: Dec 28, 2015
Last update: Jan 29, 2016

Study contacts

Senior Manager, Clinical Development

study director · Alcon Japan, Ltd.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2015. You cannot join it, but the record below documents what was studied.

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