CompletedNCT02750813Updated Jul 2, 2018Results posted

ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

An interventional study of Delefilcon A contact lenses and Senofilcon A contact lenses in Refractive Error, sponsored by Alcon, a Novartis Company. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-02.

Sponsored by Alcon, a Novartis Company (formerly part of Novartis) · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 252
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.

Conditions studied

Refractive Error

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Refractive Errors 420

In context

Refractive Errors

420 studies on the registry are indexed under Refractive Errors; 59 are open to participants now.

This study's enrollment of 252 is above the median of 76 across 301 interventional studies indexed under Refractive Errors.

Browse Refractive Errors studies →

Lead sponsor

Alcon, a Novartis Company is the lead sponsor of 13 studies on the registry; none are open to participants now.

First submitted before Alcon left Novartis.

Browse Alcon studies →All Novartis studies →

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

Who can participate

Ages eligible: 18 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

Must sign form;
Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
Cylinder equal or lower than -0.75D in both eyes;
Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
Can be successfully fitted with both study lenses at Visit 1;
Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
Other protocol-specified inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

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 as determined by the Investigator;
Monocular (only 1 eye with functional vision) or fit with only 1 lens;
Fitted with monovision;
Prior refractive surgery;
History of herpetic keratitis, ocular surgery, or irregular cornea;
Pregnant or lactating;
Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
Participation in any clinical study within 30 days of Visit 1;
Current DT1 or AO1D lens wearer;
Other protocol-specified exclusion criteria may apply.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Double (Participant, Investigator)
Enrollment: 252 participants (actual)

Study arms

Other
DT1, then AO1D
Delefilcon A contact lenses worn first, followed by senofilcon A contact lenses. Each product worn bilaterally (in both eyes) for 14 days in a daily wear, daily disposable modality.
Device: Delefilcon A contact lenses · Device: Senofilcon A contact lenses
Other
AO1D, then DT1
Senofilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 14 days in a daily wear, daily disposable modality.
Device: Delefilcon A contact lenses · Device: Senofilcon A contact lenses

Interventions

DeviceDelefilcon A contact lenses
Also known as: DAILIES TOTAL1® (DT1)
DeviceSenofilcon A contact lenses
Also known as: ACUVUE® OASYS 1-Day with HydraLuxe™ (AO1D)

What researchers measure

Primary outcomes

Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.
Time frame: Day 14, each product

Secondary outcomes

Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14
The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.
Time frame: Day 14, each product

Results

Posted Sep 26, 2017

Participant flow

Subjects were recruited from 12 study centers located in the United States.

Period 1, First 14 Days of Wear

Participant flow — Period 1, First 14 Days of Wear
Milestone	DT1, Then AO1D	AO1D, Then DT1
Started	125	121
Completed	124	120
Not completed	1	1
Withdrew: Withdrawal by subject	1	0
Withdrew: Reason not given	0	1

Period 2, Second 14 Days of Wear

Participant flow — Period 2, Second 14 Days of Wear
Milestone	DT1, Then AO1D	AO1D, Then DT1
Started	124	120
Completed	124	120
Not completed	0	0

Outcome measures

PrimaryPercentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14

Lens centration, was assessed by the investigator for each eye individually and rated on a 5-point scale: 0=centered/optimal, 1=slight decentration, 2=mild decentration, 3=moderate decentration, 4=severe decentration. The combined percentage of lenses assessed as "centered" or "slight decentration" is reported. Lenses from both eyes contributed to the percentage.

Time frame:: Day 14, each product
Reported as:: Number · percentage of lenses

Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14
percentage of lenses	DAILIES TOTAL1	AO1D
Percentage of Lenses Graded as 0 or 1 for Lens Centration at Day 14	100.0	99.4

SecondaryEx Vivo Critical Coefficient of Friction (CCOF) at Day 14

The ex vivo CCOF (ratio of the force of friction between two bodies and the force pressing them together) was measured by the incline plane technique after 16 hours of lens wear. Worn lenses were collected and analyzed for a subset of subjects (all subjects from one site only) who attended the Day 14 visit (Visit 2 and Visit 3) after 16 hours of lens wear. Only lens worn on the right eye (OD) was measured in each subject per each lens brand. CCOF values for contact lenses range from near zero to approximately 0.10 using the inclined plane method. A lower CCOF indicates higher contact lens lubricity.

Time frame:: Day 14, each product
Reported as:: Mean · unitless

Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14
unitless	DAILIES TOTAL1	AO1D
Ex Vivo Critical Coefficient of Friction (CCOF) at Day 14	0.0468 ± 0.00557	0.0675 ± 0.00599

Adverse events

Collected over Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 35 days). AEs are reported as pre-treatment and treatment-emergent.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Pretreatment	0/252 (0%)	0/252 (0%)	0/252 (0%)
DAILIES TOTAL1 (DT1)	0/246 (0%)	0/246 (0%)	0/246 (0%)
ACUVUE OASYS 1-DAY (AO1D)	0/246 (0%)	0/246 (0%)	0/246 (0%)

Baseline characteristics

This analysis population includes all randomized subjects who were exposed to any study lens, except for lenses used at Visit 1 for parameter optimization and fitting (Full Analysis Set).

Age, Continuous
Age, Continuous(years)	Overall
Mean	30.7 ± 8.44

Sex: Female, Male
Sex: Female, Male(Participants)	Overall
Female	183
Male	63

Study locations

1 site

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

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2016 to primary completion in Aug 2016, 3 months.

Results were first posted in Sep 2017, 1 year 1 month after primary completion.

Of 115 industry-sponsored interventional studies with no phase under Refractive Errors, half reached primary completion within 4 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 10. This study's 3 months is below that.

Counting every sponsor, half of 172 studies reached it within 7 months; a quarter within 2 and three quarters within 23.

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

Registered: Apr 21, 2016
First posted: Apr 26, 2016
StartActual: Apr 27, 2016
Primary completionActual: Aug 17, 2016
CompletionActual: Aug 17, 2016
Results first posted: Sep 26, 2017
Last update: Jul 2, 2018

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 Jul 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02750813
Lead sponsor: Alcon, a Novartis Company
Responsible party: Sponsor
First posted: Apr 26, 2016
Start date: Apr 27, 2016
Primary completion: Aug 17, 2016
Completion: Aug 17, 2016
Results posted: Sep 26, 2017
Last update: Jul 2, 2018

Study contacts

Sr. Clinical Manager, Global Medical Affairs, GCRA

study director · Alcon, A Novartis Division

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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