Post-market Clinical Follow-up Study of Alcon TOTAL30® Contact Lenses (Lehfilcon A)

Alcon

Status

Invitation-only

Conditions

Myopia

Astigmatism

Ametropia

Hyperopia

Treatments

Device: Lehfilcon A spherical contact lenses

Device: Lehfilcon A toric contact lenses

Study type

Observational

Funder types

Industry

Identifiers

NCT06408649

CLY935-N001

Details and patient eligibility

About

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to continuously assess the visual performance and safety of TOTAL30 Sphere and TOTAL30 for Astigmatism contact lenses in a real-world setting across a broad variety of patients through routine clinical practices.

Full description

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 TOTAL30 sphere or toric contact lens prescription was released. Baseline visit data will be collected retrospectively (chart review).

The Year 1 visit is defined as the visit that occurs 1 year (-2/+6 months) since the Baseline visit during which period the subject is wearing test lenses of the same design in both eyes, and a contact lens examination is performed. Year 1 data will be collected either retrospectively or prospectively (eye exam).

Enrollment

168 estimated patients

Sex

All

Ages

7+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

Wearers of lehfilcon A (sphere or toric) contact lenses of the same design in both eyes who have already begun use of the lens type and have purchased at least 3-month supply of lenses at the baseline timepoint;
Best corrected spectacle visual acuity (VA) 20/25 or better at baseline;
Healthy, non-diseased eyes;
Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria, as determined or known by the Investigator:

Any ocular disease or condition that would contraindicate contact lens wear present at baseline;
The use of systemic or ocular medications that would contraindicate contact lens wear at baseline;
Participation in a contact lens or contact lens care product clinical trial during the period of the retrospective chart collection or during prospective study participation;
Other protocol-specified exclusion criteria may apply.