MyopiaNCT06483113
DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study
An observational study of Myopia and Hyperopia, run by Alcon Research at 12 sites in United States.
Trial summary
The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Myopia, Hyperopia, Presbyopia
- What is being tested?
- Delefilcon A spherical soft contact lenses, Delefilcon A toric soft contact lenses and Delefilcon A multifocal soft contact lenses
- Type of treatment
- Medical device
- How many people
- 192 participants
- Where
- 12 sitesUnited States
- Study dates
- 26 Nov 2024to 27 Feb 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects will be recruited from clinical sites located in the United States.
Who may be able to join
- At baseline: 7 years of age or older for sphere and toric wearers, 40 years of age or older for multifocal wearers.
- Wearers of delefilcon A (sphere, toric, or multifocal) soft contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at baseline.
- Best corrected distance visual acuity (BCVA) 20/25 or better in each eye at baseline.
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Any ocular disease or condition that would contraindicate contact lens wear at baseline.
- Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
The Eye Doctors Inc
Eden Prairie, Minnesota, 55344
Cornea and Contact Lens Institute of Minnesota
Edina, Minnesota, 55436
Complete Eye Care of Medina
Medina, Minnesota, 55340
Optometry Group, PLLC
Memphis, Tennessee, 38111
Center for Ophthalmic and Vision Research
New York, New York, 10022
Dr. Walker and Associates
Ponte Vedra Beach, Florida, 32082
Westview Optometry
San Diego, California, 92129
Scripps Optometric Group
San Diego, California, 92131
Spokane Eye Clinic
Spokane, Washington, 99204
Koetting Associates
St Louis, Missouri, 63144
Southern Utah Medical Research
St. George, Utah, 84790
Advanced Eyecare Specialists
West Palm Beach, Florida, 33405
About this study
The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.
Read the detailed description
This study includes a Baseline visit and a Year 1 visit.
The Baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews.
The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.
- Conditions
- Myopia, Hyperopia, Presbyopia, Astigmatism
- Being tested
- Delefilcon A spherical soft contact lenses, Delefilcon A toric soft contact lenses, Delefilcon A multifocal soft contact lenses
- Keywords
- Contact lenses
- Medical subject headings
- Myopia, Hyperopia, Presbyopia, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delefilcon A spherical soft contact lensesDevice
Also called DAILIES TOTAL1® Spherical Contact Lenses
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia)
Delefilcon A toric soft contact lensesDevice
Also called DAILIES TOTAL1® for Astigmatism Contact Lenses
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism
Delefilcon A multifocal soft contact lensesDevice
Also called DAILIES TOTAL1® Multifocal Contact Lenses
Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with presbyopia
| Study group | Role | What they receive |
|---|---|---|
| DAILIES TOTAL1 Sphere | Delefilcon A spherical soft contact lenses worn in both eyes in a real-world setting Receives: Device: Delefilcon A spherical soft contact lenses | |
| DAILIES TOTAL1 Toric | Delefilcon A toric soft contact lenses worn in both eyes in a real-world setting Receives: Device: Delefilcon A toric soft contact lenses | |
| DAILIES TOTAL1 Multifocal | Delefilcon A multifocal soft contact lenses worn in both eyes in a real-world setting Receives: Device: Delefilcon A multifocal soft contact lenses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric
Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Measured: Baseline
Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric
Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Measured: Year 1 Follow-Up
Distance visual acuity with study lenses at Baseline - Multifocal
Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Measured: Baseline
Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal
Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Measured: Year 1 Follow-Up
Near visual acuity with study lenses at Baseline - Multifocal
Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Measured: Baseline
Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal
Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Measured: Year 1 Follow-Up
Incidence of corneal infiltrative events
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Measured: Up to Year 1
Incidence of microbial keratitis
Microbial keratitis is a sight-threatening infection of the cornea.
Measured: Up to Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start26 Nov 2024
- Primary completion27 Feb 2025
- Study completion27 Feb 2025
Why it stopped: Management decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Lead, Vision Care, Study director, Alcon Research, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483113
- Sponsor's protocol ID
- CLU484-N001
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2024
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study
- ClinicalTrials.gov ID
- NCT06483113
- Acronym / sponsor ID
- CLU484-N001
- Conditions
- Myopia, Hyperopia, Presbyopia, Astigmatism
- Keywords
- Contact lenses
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 27 Feb 2025 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 3 Jul 2024 (actual)
- Results
- Not posted in the source record
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 continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.
Detailed description
This study includes a Baseline visit and a Year 1 visit.
The Baseline visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews.
The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DAILIES TOTAL1 Sphere | – | Device: Delefilcon A spherical soft contact lensesDelefilcon A spherical soft contact lenses worn in both eyes in a real-world setting |
| DAILIES TOTAL1 Toric | – | Device: Delefilcon A toric soft contact lensesDelefilcon A toric soft contact lenses worn in both eyes in a real-world setting |
| DAILIES TOTAL1 Multifocal | – | Device: Delefilcon A multifocal soft contact lensesDelefilcon A multifocal soft contact lenses worn in both eyes in a real-world setting |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects will be recruited from clinical sites located in the United States.
Key inclusion criteria (4 listed)
- At baseline: 7 years of age or older for sphere and toric wearers, 40 years of age or older for multifocal wearers.
- Wearers of delefilcon A (sphere, toric, or multifocal) soft contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at baseline.
- Best corrected distance visual acuity (BCVA) 20/25 or better in each eye at baseline.
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Any ocular disease or condition that would contraindicate contact lens wear at baseline.
- Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
- Other protocol-defined exclusion criteria may apply.
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 spherical soft contact lensesAlso: DAILIES TOTAL1® Spherical Contact LensesSilicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) | Device | DAILIES TOTAL1 Sphere |
| Delefilcon A toric soft contact lensesAlso: DAILIES TOTAL1® for Astigmatism Contact LensesSilicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism | Device | DAILIES TOTAL1 Toric |
| Delefilcon A multifocal soft contact lensesAlso: DAILIES TOTAL1® Multifocal Contact LensesSilicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with presbyopia | Device | DAILIES TOTAL1 Multifocal |
Primary outcome
Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric
Time frame: Baseline
Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Distance visual acuity with study lenses at Year 1 Follow-up - Sphere and Toric
Time frame: Year 1 Follow-Up
Distance VA will be assessed for each eye individually with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 spherical contact lenses and DAILIES TOTAL1 for Astigmatism contact lenses.
Distance visual acuity with study lenses at Baseline - Multifocal
Time frame: Baseline
Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Distance visual acuity with study lenses at Year 1 Follow-Up - Multifocal
Time frame: Year 1 Follow-Up
Distance visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Near visual acuity with study lenses at Baseline - Multifocal
Time frame: Baseline
Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Near visual acuity with study lenses at Year 1 Follow-Up - Multifocal
Time frame: Year 1 Follow-Up
Near visual acuity will be assessed for both eyes together with study lenses in place and recorded in Snellen. This endpoint is prespecified for DAILIES TOTAL1 multifocal contact lenses.
Incidence of corneal infiltrative events
Time frame: Up to Year 1
A corneal infiltrate is a single or group of inflammatory cells in the normally clear cornea.
Incidence of microbial keratitis
Time frame: Up to Year 1
Microbial keratitis is a sight-threatening infection of the cornea.
Results and safety
The study was stopped early (reason given: Management decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2025.
- Individual participant dataSharing planned: No
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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 Trial Lead, Vision Care study director
Alcon Research, LLC
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia and Hyperopia, run by Alcon Research at 12 sites in United States.
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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. 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?
The study was stopped early (reason given: Management decision). Results are not available in the source record.
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?
Distance visual acuity (VA) with study lenses at Baseline - Sphere and Toric (time frame: Baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2025.