NCT06483113

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 192 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Myopia
• Hyperopia
• Presbyopia
• Astigmatism

Interventions

Type	Name	Description
DEVICE	Delefilcon A spherical soft contact lenses	Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia)
DEVICE	Delefilcon A toric soft contact lenses	Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with astigmatism
DEVICE	Delefilcon A multifocal soft contact lenses	Silicone hydrogel contact lenses prescribed for single use, daily disposable wear (less than 24 hours while awake) for the correction of ametropia (myopia or hyperopia) with presbyopia

Timeline

• Start date: 2024-11-26
• Primary completion: 2025-02-27
• Completion: 2025-02-27
• First posted: 2024-07-03
• Last updated: 2025-07-20

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study