Clinical Comparison of Two Daily Disposable Contact Lenses - Pilot Study 3

Alcon

Status: Completed

Conditions: Myopia; Ametropia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04942925

CLE383-E002

Details and patient eligibility

About

The purpose of this study is to evaluate the overall performance of PRECISION1™ contact lenses when compared to INFUSE™ contact lenses.

Full description

The expected duration of subject participation in the study is up to 24 days with 3 scheduled visits.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Able to understand and sign an Informed Consent Form that been approved by an Institutional Review Board.
• Successful wear of spherical soft contact lenses in both eyes for a minimum of 5 days per week and 10 hours per day during the past 3 months.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Current/previous PRECISION1 or INFUSE contact lens wearer.
• Any eye condition or use of medication that contraindicates contact lens wear, as determined by the investigator.
• Routinely sleeps in 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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60 participants in 2 patient groups

Precision1, then Infuse

Other group

Description:

Verofilcon 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 in a daily disposable modality.

Treatment:

Device: Kalifilcon A contact lenses

Device: Verofilcon A contact lenses

Infuse, then Precision1

Other group

Description:

Kalifilcon A contact lenses worn first, with verofilcon A 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: Kalifilcon A contact lenses

Device: Verofilcon A contact lenses