Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Not Applicable

Completed

• Conditions: Ametropia; Refractive Errors; Myopia
• Interventions: Device: Delefilcon A contact lenses; Device: Kalifilcon A contact lenses

• Registration Number: NCT05010512
• Lead Sponsor: Alcon Research

Brief Summary

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

• Study First Submitted: 2021-08-11
• Study First Submitted QC: 2021-08-11
• Study First Posted: 2021-08-18
• Study Start: 2021-08-31
• Primary Completion: 2021-10-12
• Study Completion: 2021-10-12
• Status Verified: 2022-10
• Results First Submitted: 2022-10-11
• Results First Submitted QC: 2022-10-11
• Last Update Submitted: 2022-10-11
• Results First Posted: 2022-11-08
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Infuse, then DT1	Kalifilcon A contact lenses	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.
Infuse, then DT1	Delefilcon A contact lenses	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.
DT1, then Infuse	Delefilcon A contact lenses	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.
DT1, then Infuse	Kalifilcon A contact lenses	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.

Primary Outcome Measures

Name	Time	Method
Least Squares Mean Distance VA (logMAR) With Study Lenses	Day 8 (-0/+3), each study lens type	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.

Trial Locations

Locations (8)

Alcon Investigator 6355; 🇺🇸 Orlando, Florida, United States

Alcon Investigator 3950; 🇺🇸 Bloomington, Illinois, United States

Alcon Investigator 6353; 🇺🇸 Memphis, Tennessee, United States

Alcon Investigator 6614; 🇺🇸 Franklin Park, Illinois, United States

Alcon Investigator 6583; 🇺🇸 Eden Prairie, Minnesota, United States

Alcon Investigator 3382; 🇺🇸 Wyomissing, Pennsylvania, United States

Alcon Investigator 2786; 🇺🇸 Memphis, Tennessee, United States

Alcon Investigator 6418; 🇺🇸 Tallahassee, Florida, United States