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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06408649
• Other study ID #: CLY935-N001
• Status: Not yet recruiting
• Start date: August 2024
• Est. completion date: December 2026

Study information

• Verified date: June 2024
• Source: Alcon Research
• Contact: Alcon Call Center
• Phone: 1-888-451-3937
• Email: alcon.medinfo[@]alcon.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 168
• Est. completion date: December 2026
• Est. primary completion date: March 2026
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ametropia
• Astigmatism
• Hyperopia
• Myopia
• Refractive Errors

Intervention

Device:
• Lehfilcon A spherical contact lenses
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia)
• Lehfilcon A toric contact lenses
Silicone hydrogel contact lenses for the correction of ametropia (myopia or hyperopia) with astigmatism

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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