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

NCT06408649 | Terminated FDA Device

• 1 other identifier: CLY935-N001
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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.

Conditions

Ametropia; Myopia; Hyperopia; Astigmatism

Keywords

Contact lenses

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

TOTAL30 Sphere

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

Device: Lehfilcon A 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

Interventions

Lehfilcon A spherical contact lenses DEVICE

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

Also known as: TOTAL30® Spherical Contact Lenses

TOTAL30 Sphere

Lehfilcon A toric contact lenses DEVICE

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

Also known as: TOTAL30® for Astigmatism Contact Lenses

TOTAL30 for Astigmatism

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Refractive Errors; Myopia; Hyperopia; Astigmatism

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 10, 2024
• Study Start: November 15, 2024
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)