An observational study in Myopia, Hyperopia and Presbyopia, sponsored by Alcon Research. Terminated at 12 sites in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2025-07-20.
Sponsored by Alcon Research (part of Alcon) · Observational
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.
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's enrollment of 192 is above the median of 150 across 204 observational studies indexed under Myopia.
Browse Myopia studies →Alcon Research is the lead sponsor of 624 studies on the registry; 9 are open to participants now.
Of its 112 completed or terminated interventional studies of FDA-regulated products, 102 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited from clinical sites located in the United States.
Key Inclusion Criteria:
Key Exclusion Criteria:
Delefilcon A spherical soft contact lenses worn in both eyes in a real-world setting
Device: Delefilcon A spherical soft contact lenses
Delefilcon A toric soft contact lenses worn in both eyes in a real-world setting
Device: Delefilcon A toric soft contact lenses
Delefilcon A multifocal soft contact lenses worn in both eyes in a real-world setting
Device: Delefilcon A multifocal soft 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)
Also known as: 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) with astigmatism
Also known as: 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 presbyopia
Also known as: DAILIES TOTAL1® Multifocal Contact Lenses
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to Year 1
Incidence of microbial keratitis
Microbial keratitis is a sight-threatening infection of the cornea.
Time frame: Up to Year 1
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2024 to primary completion in Feb 2025, 3 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.