DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up 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.

Study Overview

• Status: Terminated
• Conditions: Presbyopia; Astigmatism; Myopia; Hyperopia
• Intervention / Treatment: Device: Delefilcon A spherical soft contact lenses; Device: Delefilcon A toric soft contact lenses; Device: Delefilcon A multifocal soft contact lenses

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 Type: Observational
• Enrollment (Actual): 192

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92129
      • Westview Optometry
    • San Diego, California, United States, 92131
      • Scripps Optometric Group
  • Florida
    • Ponte Vedra Beach, Florida, United States, 32082
      • Dr. Walker and Associates
    • West Palm Beach, Florida, United States, 33405
      • Advanced Eyecare Specialists
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • The Eye Doctors Inc
    • Edina, Minnesota, United States, 55436
      • Cornea and Contact Lens Institute of Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Koetting Associates
  • New York
    • New York, New York, United States, 10022
      • Center for Ophthalmic and Vision Research
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Optometry Group, PLLC
  • Utah
    • Saint George, Utah, United States, 84790
      • Southern Utah Medical Research
  • Washington
    • Spokane, Washington, United States, 99204
      • Spokane Eye Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from clinical sites located in the United States.

Description

Key Inclusion Criteria:

• 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:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DAILIES TOTAL1 Sphere; Delefilcon A spherical soft contact lenses worn in both eyes in a real-world setting	Device: Delefilcon A spherical 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); Other Names: DAILIES TOTAL1® Spherical Contact Lenses
DAILIES TOTAL1 Toric; Delefilcon A toric soft contact lenses worn in both eyes in a real-world setting	Device: Delefilcon A toric 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) with astigmatism; Other Names: DAILIES TOTAL1® for Astigmatism Contact Lenses
DAILIES TOTAL1 Multifocal; 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) with presbyopia; Other Names: DAILIES TOTAL1® Multifocal Contact Lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	Up to Year 1
Incidence of microbial keratitis	Microbial keratitis is a sight-threatening infection of the cornea.	Up to Year 1

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2024
• Primary Completion (Actual): February 27, 2025
• Study Completion (Actual): February 27, 2025

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism; Hyperopia; Presbyopia
• Other Study ID Numbers: CLU484-N001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No