Clinical Comparison of Two Daily Disposable Toric Soft Contact Lenses

Alcon

Status: Completed

Conditions: Myopia; Ametropia; Astigmatism

Treatments: Device: Verofilcon A toric soft contact lenses; Device: Stenfilcon A toric soft contact lenses

Study type: Interventional

Funder types: Industry

Identifiers

NCT05483127

CLA306-P002

Details and patient eligibility

About

The primary purpose of this study is to demonstrate noninferiority in the visual acuity at distance when wearing PRECISION1™ for Astigmatism (P1fA) soft contact lenses compared to another commercially available, soft toric contact lens, MyDay® toric (MDT).

Full description

Study participants will wear each study lens type in 1 of 2 randomized, crossover sequences. Participants will be expected to attend 4 visits and wear study lenses for at least 10 hours per day. The total duration of an individual's participation in the study will be up to 28 days.

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Successful wearers of toric soft contact lenses in both eyes with at least 3 months wearing experience, with a minimum wearing time of 5 days per week and 10 hours per day.
• Able to wear contact lenses within a range of sphere & cylinder power and axes.
• Willing to NOT use rewetting/lubricating drops at any time during the study.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current or previous P1fA and MDT habitual lens wearers.
• Monovision and multifocal lens wearers.
• Participation of the subject in a clinical trial within the previous 30 days or currently enrolled in any clinical trial.
• 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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153 participants in 2 patient groups

P1fA, then MDT

Other group

Description:

Verofilcon A toric soft contact lenses worn first, followed by stenfilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.

Treatment:

Device: Stenfilcon A toric soft contact lenses

Device: Verofilcon A toric soft contact lenses

MDT, then P1fA

Other group

Description:

Stenfilcon A toric soft contact lenses worn first, followed by verofilcon A toric soft contact lenses, as randomized. Each study lens type will be worn for 8 (-0/+3) days for at least 10 hours per day. Lenses will be removed nightly and disposed of after a single use.

Treatment:

Device: Stenfilcon A toric soft contact lenses

Device: Verofilcon A toric soft contact lenses