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)

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.

Study Overview

• Status: Terminated
• Conditions: Astigmatism; Myopia; Hyperopia; Ametropia
• Intervention / Treatment: Device: Lehfilcon A spherical contact lenses; Device: Lehfilcon A toric contact lenses

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 Type: Observational
• Enrollment (Actual): 129

Contacts and Locations

Study Locations

• United States
  • Texas
    • Fort Worth, Texas, United States, 76134
      • Contact Alcon Call Center for Trial Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from clinical sites located in the United States.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
TOTAL30 Sphere; Lehfilcon A spherical contact lenses worn in both eyes in a real-world setting	Device: Lehfilcon A spherical contact lenses; Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia); Other Names: TOTAL30® Spherical Contact Lenses
TOTAL30 for Astigmatism; Lehfilcon A toric contact lenses worn in both eyes in a real-world setting	Device: Lehfilcon A toric contact lenses; Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism; Other Names: TOTAL30® for Astigmatism Contact Lenses

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2024
• Primary Completion (Actual): April 22, 2025
• Study Completion (Actual): April 22, 2025

Study Registration Dates

• First Submitted: May 7, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Contact lenses
• Additional Relevant MeSH Terms: Eye Diseases; Astigmatism; Hyperopia; Refractive Errors
• Other Study ID Numbers: CLY935-N001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No