NCT05886894

Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 351 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or extended (overnight) wear.

Detailed description

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. The baseline visit will be defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for the study or comparator contact lenses was released. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Lotrafilcon B multifocal soft contact lenses	Commercially available soft (hydrophilic) contact lenses indicated for the correction of presbyopia, with or without myopia or hyperopia
DEVICE	Comfilcon A multifocal soft contact lenses	Commercially available soft (hydrophilic) contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia

Timeline

• Start date: 2023-08-08
• Primary completion: 2025-06-20
• Completion: 2025-06-20
• First posted: 2023-06-02
• Last updated: 2025-08-14

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study