Clinical Performance of Two Daily Disposable Toric Soft Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors; Astigmatism; Ametropia

Treatments: Device: Etafilcon A toric contact lenses; Device: Verofilcon A toric contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT04908488

CLA306-P001

Details and patient eligibility

About

The purpose of this study is to compare the clinical performance of PRECISION1™ for Astigmatism (P1fA) contact lenses with 1-DAY ACUVUE MOIST® for ASTIGMATISM (AMfA) contact lenses.

Full description

Subjects will be expected to attend 4 visits and wear study lenses daily for at least 10 hours per day. The total duration of subject participation will be up to 22 days.

Enrollment: 115 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful wear of toric soft contact lenses in both eyes for a a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Habitual PRECISION1 for Astigmatism or 1-DAY ACUVUE MOIST for ASTIGMATISM contact lens wearers.
• Any spherical monovision and multifocal lens wearers.
• Routinely sleeping in contact lenses for at least 1 night per week over the last 3 months prior to enrollment.
• 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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115 participants in 2 patient groups

P1fA, then AMfA

Other group

Description:

Verofilcon A toric contact lenses worn first, with etafilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Treatment:

Device: Verofilcon A toric contact lenses

Device: Etafilcon A toric contact lenses

AMfA, then P1fA

Other group

Description:

Etafilcon A toric contact lenses worn first, with verofilcon A toric contact lenses worn second, as randomized. Each study lens type will be worn bilaterally (in both eyes) for 8 -0/+3 days in a daily disposable modality.

Treatment:

Device: Verofilcon A toric contact lenses

Device: Etafilcon A toric contact lenses