DAILIES TOTAL1® Soft Contact Lenses - Post-Market Clinical Follow-up Study

Launched by ALCON RESEARCH · Jun 26, 2024

Keywords

ClinConnect Summary

This study includes a Baseline visit and a Year 1 visit.

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 DAILIES TOTAL1 sphere, toric, or multifocal soft contact lens prescription was released. The Baseline visit will be retrospective. All assessments at baseline will be obtained from chart reviews.

The Year 1 visit is defined as the visit that occurs 1 year (-2/+4 months) since the Baseline visit during which period the subject is wearing prescribed lenses and a ...

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• • At baseline: 7 years of age or older for sphere and toric wearers, 40 years of age or older for multifocal wearers.
• • Wearers of delefilcon A (sphere, toric, or multifocal) soft 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 baseline.
• • Best corrected distance visual acuity (BCVA) 20/25 or better in each eye at baseline.
• • Other protocol-defined inclusion criteria may apply.
• Key Exclusion Criteria:
• • Any ocular disease or condition that would contraindicate contact lens wear at baseline.
• • Use of systemic or ocular medications that would contraindicate contact lens wear at baseline.
• • Other protocol-defined exclusion criteria may apply.