Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses

Alcon

Status: Terminated

Conditions: Refractive Errors

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

Study type: Observational

Funder types: Industry

Identifiers

NCT06462456

CLE383-I001

Details and patient eligibility

About

The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.

Full description

This study consists of a Baseline Visit and a Year 1 Visit.

The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject before or during which a PRECISION1™ sphere or toric contact lens prescription was released. The Baseline Visit will be retrospective, with all assessments obtained from chart review.

The Year 1 Visit is defined as the visit that occurs 1 year (-2/+4 months) since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit. The Year 1 Visit may be prospective or retrospective.

Enrollment: 140 patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subject (or subject's legal representative) is able to understand and sign an informed consent/assent form approved by an Institutional Review Board (IRB), unless appropriate consent waiver for the retrospective chart review is provided by the IRB.
• Verofilcon A (sphere or toric) contact lens wear as described in the protocol.
• Best corrected spectacle distance visual acuity (VA) 20/25 or better at baseline.
• Healthy, non-diseased eyes, as determined/known by the Investigator.
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Any ocular disease or condition that would contraindicate contact lens wear present at baseline.
• Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
• Other protocol-defined exclusion criteria may apply.

Trial design

140 participants in 2 patient groups

PRECISION1 Sphere

Description:

Verofilcon A spherical soft contact lenses worn in both eyes in a real-world setting

Treatment:

Device: Verofilcon A spherical soft contact lenses

PRECISION1 Toric

Description:

Verofilcon A toric soft contact lenses worn in both eyes in a real-world setting

Treatment:

Device: Verofilcon A toric soft contact lenses