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

Launched by ALCON RESEARCH · May 7, 2024

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• 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.