NCT06408649

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

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 129 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: —

Summary

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.

Detailed 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).

Conditions

• Ametropia
• Myopia
• Hyperopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Lehfilcon A spherical contact lenses	Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia)
DEVICE	Lehfilcon A toric contact lenses	Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism

Timeline

• Start date: 2024-11-15
• Primary completion: 2025-04-22
• Completion: 2025-04-22
• First posted: 2024-05-10
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study