MyopiaFOXNCT06308666

Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use

A study testing Delefilcon A contact lenses in people with Myopia, run by University of Waterloo at 1 site in Canada.

Completed

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

Trial summary

The purpose of this study is to evaluate the performance of DAILIES TOTAL1 daily disposable contact lenses with regards to subjective symptoms (comfort, dryness, vision) in lens wearers who use identify themselves as substantial digital device users (at least eight hours of digital device use per day). Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Myopia
What is being tested?: Delefilcon A contact lenses
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: 1 siteCanada
Study dates: 18 Mar 2024to 23 Oct 2024
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 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
Have read and signed an information consent letter;
Are willing and able to follow instructions and maintain the appointment schedule;
Are a digital device user (at least 8 hours on a typical day using any combination of digital devices such as personal computer [PC], laptop, smartphone or tablet);
Are a habitual wearer of daily wear, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 13+ hours/day on a typical day during the month prior to enrolment;
The habitual lens type brand will be restricted such that a maximum of 7 participants will be included in the study for each lens brand/material;

Show all 10Show fewer

Have a vertex corrected spherical equivalent distance refraction within -0.50 Diopter (D) to -9.00D in each eye;
Have a vertex corrected refractive cylinder ≤ -0.75 cylindrical correction in each eye after vertexing to the corneal plane;
Demonstrate an acceptable fit and achieves best corrected visual acuity of at least 0.10 logMAR in each eye with DAILIES TOTAL1® contact lenses;
Are willing to wear DAILIES TOTAL1® contact lenses at least 5 days per week and 13+ hours per day throughout the study.

Who cannot join

Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
Are presbyopic or habitually use a reading addition for close work;
Have any known active* ocular disease and/or infection; [* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.]
Meet the diagnosis of dry eye disease as per the following combination:
Meets the symptom criteria of Contact Lens Dry Eye Questionnaire (CLDEQ-8) score ≥12
And they show 1 of the following 2 signs:

Show all 14Show fewer

Either sodium fluorescein (NaFl) staining (either [cornea >5 dots] or [conjunctiva >9 dots] or [lid margin >2mm length AND ≥25% width]);
Or non-invasive tear film break-up time (NITBUT) (no contact lens) <10 seconds.
Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;+ [+ Any potential exclusion will be reviewed with the Lead Investigator or Principal Investigator prior to final decision making.]
Are using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
Are a current wearer of DAILIES TOTAL1® daily disposable contact lenses;
Have known sensitivity to the diagnostic pharmaceutical sodium fluorescein to be used in the study;
Have undergone refractive error surgery;
Are a member of the Centre for Ocular Research \& Education (CORE) directly involved in the study.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Ocular Research & Education
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

Conditions: Myopia
Being tested: Delefilcon A contact lenses
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®
Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia

Study groups in NCT06308666
Study group	Role	What they receive
Refit	Experimental	Refit and dispense participant with delefilcon A contact lenses and evaluate lens performance Receives: Device: Delefilcon A contact lenses

What is being measured

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

Subjective Rating of Comfort After 8 Hours or More of Digital Device Use
Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 14+2
Subjective Rating of Dryness After 8 Hours or More of Digital Device Use
Participants rate their overall dryness after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 14+2
Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use
Participants rate their overall clarity of vision after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Measured: Day 14+2

Timeline

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

18 Mar 202423 Oct 2024

First posted13 Mar 2024
Study start18 Mar 2024
Primary completion23 Oct 2024
Study completion23 Oct 2024

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06308666
Sponsor's protocol ID: 46091
Acronym: FOX
Status last verified: Dec 2024
First submitted: 6 Mar 2024
Last updated: 31 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: 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 31 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Performance of DAILIES TOTAL1 Daily Disposable Contact Lenses in Habitual Soft Lens Wearers Who Report Substantial Digital Device Use
ClinicalTrials.gov ID: NCT06308666
Acronym / sponsor ID: FOX / 46091
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Collaborators: Alcon Research
Study start: 18 Mar 2024 (actual)
Primary completion: 23 Oct 2024 (actual)
Study completion: 23 Oct 2024 (actual)
First posted: 13 Mar 2024 (actual)
Results: Posted 31 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Refit	Experimental	Device: Delefilcon A contact lensesRefit and dispense participant with delefilcon A contact lenses and evaluate lens performance

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

Are between 18 and 40 years of age (inclusive) and has full legal capacity to volunteer;
Have read and signed an information consent letter;
Are willing and able to follow instructions and maintain the appointment schedule;
Are a digital device user (at least 8 hours on a typical day using any combination of digital devices such as personal computer [PC], laptop, smartphone or tablet);
Are a habitual wearer of daily wear, spherical, soft contact lenses (no bifocal or multifocal contact lenses, no extended wear or monovision) for at least 5 days/week and at least 13+ hours/day on a typical day during the month prior to enrolment;

Key exclusion criteria (14 listed)

Are participating in any concurrent clinical or research study involving intervention or invasive ocular tests;
Are presbyopic or habitually use a reading addition for close work;
Have any known active* ocular disease and/or infection; [* For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and mild dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.]
Meet the diagnosis of dry eye disease as per the following combination:
Have a systemic condition that in the opinion of the investigator may affect a study outcome variable;+ [+ Any potential exclusion will be reviewed with the Lead Investigator or Principal Investigator prior to final decision making.]

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®Daily disposable silicone hydrogel contact lenses indicated for the optical correction of myopia and hyperopia	Device	Refit

Primary outcome

Subjective Rating of Comfort After 8 Hours or More of Digital Device Use
Time frame: Day 14+2
Participants rate their overall comfort after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Dryness After 8 Hours or More of Digital Device Use
Time frame: Day 14+2
Participants rate their overall dryness after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).
Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use
Time frame: Day 14+2
Participants rate their overall clarity of vision after 8 hours or more of digital device use on a scale from 0 (worst) to 100 (best).

Results and safety

Results posted to the registry on 31 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Refit	35	32

Primary outcome: Subjective Rating of Comfort After 8 Hours or More of Digital Device Use

Time frame: Day 14+2. Median (Full Range). Unit: score on a scale

Measure	Refit n = 32
Value	96 (70 to 100)

Population analysed: 3 people discontinued before the study could be completed.

Primary outcome: Subjective Rating of Dryness After 8 Hours or More of Digital Device Use

Time frame: Day 14+2. Median (Full Range). Unit: score on a scale

Measure	Refit n = 32
Value	93 (50 to 100)

Population analysed: 3 people discontinued before the study could be completed.

Primary outcome: Subjective Rating of Clarity of Vision After 8 Hours or More of Digital Device Use

Time frame: Day 14+2. Median (Full Range). Unit: score on a scale

Measure	Refit n = 32
Value	95 (75 to 100)

Population analysed: 3 people discontinued before the study could be completed.

Adverse events

Time frame: 2 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Refit	0 of 35 (0%)	0 of 35 (0%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

Lyndon Jones, PhD, FCOptom principal investigator

Centre for Ocular Research & Education

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 in people with Myopia, run by University of Waterloo at 1 site in Canada.

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 10 inclusion and 14 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 31 Oct 2025. 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 Canada. 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 31 Oct 2025). 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?

Subjective Rating of Comfort After 8 Hours or More of Digital Device Use (time frame: Day 14+2). The study lists 3 primary outcomes in all. 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 NCT06308666.

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 31 Oct 2025.