NCT06462456

Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical and PRECISION1™ for Astigmatism Soft Contact Lenses

Post-market Clinical Follow-up Study of Alcon PRECISION1™ Spherical Soft Contact Lenses (Verofilcon A) and PRECISION1T™ for Astigmatism Contact Lenses (Verofilcon A)

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess long term performance and safety of verofilcon A soft contact lenses in a real-world setting in a population of 7 years or older having at least 1 year of verofilcon A (sphere or toric) contact lens wear in a daily wear and daily disposable modality.

Detailed description

This study consists of 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 PRECISION1™ sphere or toric contact lens prescription was released. The Baseline Visit will be retrospective, with all assessments obtained from chart review. The Year 1 Visit is defined as the visit that occurs 1 year (-2/+4 months) since Baseline during which period the subject is wearing test lenses of the same design in both eyes and a contact lens examination is performed during the visit. The Year 1 Visit may be prospective or retrospective.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Verofilcon 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	Verofilcon 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

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-03-11
• Completion: 2025-03-11
• First posted: 2024-06-17
• Last updated: 2025-07-20

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated device study