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

NCT ID: NCT06408649

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 129 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-11-15
• Study Completion Date: 2025-04-22

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).

Conditions

Ametropia; Myopia; Hyperopia; Astigmatism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

TOTAL30 Sphere

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

Lehfilcon A spherical contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia)

TOTAL30 for Astigmatism

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

Lehfilcon A toric contact lenses

Intervention Type: DEVICE

Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism

Interventions

Lehfilcon A spherical contact lenses

Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia)

Intervention Type: DEVICE

Lehfilcon A toric contact lenses

Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism

Intervention Type: DEVICE

Other Intervention Names

TOTAL30® Spherical Contact Lenses; TOTAL30® for Astigmatism Contact Lenses

Eligibility Criteria

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;

Exclusion Criteria

• 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;

• Minimum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Lead, Vision Care

Role: STUDY_DIRECTOR

Alcon Research, LLC

Locations

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

CLY935-N001

Identifier Type: -

Identifier Source: org_study_id