Clinical Performance of Two Commercial, Daily Disposable Contact Lenses

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors; Ametropia

Treatments: Device: Kalifilcon A contact lenses; Device: Delefilcon A contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05010512

CLU484-P002

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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112 participants in 2 patient groups

DT1, then Infuse

Other group

Description:

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.

Treatment:

Device: Delefilcon A contact lenses

Device: Kalifilcon A contact lenses

Infuse, then DT1

Other group

Description:

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.

Treatment:

Device: Delefilcon A contact lenses

Device: Kalifilcon A contact lenses