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

NCT06483113 | Terminated FDA Device

• 1 other identifier: CLU484-N001
• Study Type: observational
• Target: 192
• Locations: 1 country
• Sites: 12

Brief 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. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.

Conditions

Myopia; Hyperopia; Presbyopia; Astigmatism

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (3)

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

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

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

Interventions

Delefilcon A spherical soft contact lenses DEVICE

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

DAILIES TOTAL1 Sphere

Delefilcon A toric soft contact lenses DEVICE

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

DAILIES TOTAL1 Toric

Delefilcon A multifocal soft contact lenses DEVICE

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

DAILIES TOTAL1 Multifocal

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (12)

Westview Optometry

San Diego, California, 92129, United States

Location

Scripps Optometric Group

San Diego, California, 92131, United States

Location

Dr. Walker and Associates

Ponte Vedra Beach, Florida, 32082, United States

Location

Advanced Eyecare Specialists

West Palm Beach, Florida, 33405, United States

Location

The Eye Doctors Inc

Eden Prairie, Minnesota, 55344, United States

Location

Cornea and Contact Lens Institute of Minnesota

Edina, Minnesota, 55436, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Koetting Associates

St Louis, Missouri, 63144, United States

Location

Center for Ophthalmic and Vision Research

New York, New York, 10022, United States

Location

Optometry Group, PLLC

Memphis, Tennessee, 38111, United States

Location

Southern Utah Medical Research

St. George, Utah, 84790, United States

Location

Spokane Eye Clinic

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Myopia; Hyperopia; Presbyopia; Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: November 26, 2024
• Primary Completion: February 27, 2025
• Study Completion: February 27, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (12)