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

• Conditions: Myopia; Ametropia; Hyperopia; Astigmatism
• Interventions: Device: Lehfilcon A spherical contact lenses; Device: Lehfilcon A toric contact lenses

• Registration Number: NCT06408649
• Lead Sponsor: Alcon Research

Brief 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).

Study Timeline

• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-07
• Study First Posted: 2024-05-10
• Study Start: 2024-11-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16
• Primary Completion: 2027-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 168

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TOTAL30 Sphere	Lehfilcon A spherical contact lenses	Lehfilcon A spherical contact lenses worn in both eyes in a real-world setting
TOTAL30 for Astigmatism	Lehfilcon A toric contact lenses	Lehfilcon A toric contact lenses worn in both eyes in a real-world setting

Primary Outcome Measures

Name	Time	Method
Distance visual acuity with study lenses at 1-year follow-up	Year 1	Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.
Incidence of corneal infiltrative events	Up to Year 1	Incidence of corneal infiltrative events occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
Incidence of microbial keratitis	Up to Year 1	Incidence of microbial keratitis occurring after the Baseline Visit will be determined retrospectively (chart review) and prospectively (eye exam).
Distance visual acuity with study lenses at baseline	Baseline	Visual acuity (VA) assessed per the investigator's standard of care with study lenses in place.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States