Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

The purpose of this study is to compare the clinical performance of DAILIES TOTAL1 ( DT1) contact lenses with Infuse contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Errors; Myopia; Ametropia
• Intervention / Treatment: Device: Delefilcon A contact lenses; Device: Kalifilcon A contact lenses

Detailed Description

Subjects will wear two products and be expected to attend 3 office visits. The individual duration of participation will be approximately 3 weeks, which includes 16 to 22 days of lens wear.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32803
      • Alcon Investigator 6355
    • Tallahassee, Florida, United States, 32308
      • Alcon Investigator 6418
  • Illinois
    • Bloomington, Illinois, United States, 61704
      • Alcon Investigator 3950
    • Franklin Park, Illinois, United States, 60131
      • Alcon Investigator 6614
  • Minnesota
    • Eden Prairie, Minnesota, United States, 55344
      • Alcon Investigator 6583
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States, 19610
      • Alcon Investigator 3382
  • Tennessee
    • Memphis, Tennessee, United States, 38111
      • Alcon Investigator 6353
    • Memphis, Tennessee, United States, 38119
      • Alcon Investigator 2786

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Habitually wears soft contact lenses in both eyes at least 5 days per week and at least 10 hours per day;
• At least 3 months of contact lens wearing experience;
• Less than or equal to 0.75 diopter (D) astigmatism in each eye;
• Best Corrected Visual Acuity (BCVA) better than or equal to 20/25 in each eye.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current/previous DAILIES TOTAL1 and/or Infuse habitual lens wearer;
• Monovision and/or multifocal lens wearer;
• Routinely sleeps in habitual contact lenses.
• Other protocol-defined exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DT1, then Infuse; Delefilcon A contact lenses worn first, with kalifilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.	Device: Delefilcon A contact lenses; Commercially available silicone hydrogel contact lenses used as indicated; Other Names: DAILIES TOTAL1®; DT1; Device: Kalifilcon A contact lenses; Commercially available silicone hydrogel contact lenses used as indicated; Other Names: Infuse; Bausch + Lomb INFUSE™
Other: Infuse, then DT1; Kalifilcon A contact lenses worn first, with delefilcon A contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 (-0/+3) days on a daily wear, daily disposable basis.	Device: Delefilcon A contact lenses; Commercially available silicone hydrogel contact lenses used as indicated; Other Names: DAILIES TOTAL1®; DT1; Device: Kalifilcon A contact lenses; Commercially available silicone hydrogel contact lenses used as indicated; Other Names: Infuse; Bausch + Lomb INFUSE™

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Least Squares Mean Distance VA (logMAR) With Study Lenses	Distance visual acuity (VA) was assessed with study lenses in place. VA was collected for each eye separately using logarithmic of the Minimum Angle of Resolution (logMAR) charts. A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal visual acuity), with a negative value denoting better than 20/20 visual acuity.	Day 8 (-0/+3), each study lens type

Collaborators and Investigators

• Sponsor: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): October 12, 2021
• Study Completion (Actual): October 12, 2021

Study Registration Dates

• First Submitted: August 11, 2021
• First Submitted That Met QC Criteria: August 11, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: October 11, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLU484-P002

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