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

Alcon

Status

Invitation-only

Conditions

Myopia

Astigmatism

Presbyopia

Hyperopia

Treatments

Device: Delefilcon A spherical soft contact lenses

Device: Delefilcon A toric soft contact lenses

Device: Delefilcon A multifocal soft contact lenses

Study type

Observational

Funder types

Industry

Identifiers

NCT06483113

CLU484-N001

Details and patient eligibility

About

The purpose of this study is to continuously assess the visual performance and safety of DAILIES TOTAL1 soft contact lenses in a real world setting and broader patient base through routine clinical practices. This activity will be used to continuously support delefilcon A (sphere, toric, and multifocal) soft contact lens regulatory requirements and standards.

Full description

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 contact lens examination is performed. The Year 1 visit can be either retrospective or prospective in subjects 7 to less than 18 years of age. For subjects 18 years of age and older, the Year 1 visit will be retrospective.

Enrollment

224 estimated patients

Sex

All

Ages

7+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.