NCT05886881

Air Optix Extended Wear Contact Lenses

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 505 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 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 Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as 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. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Lotrafilcon B spherical soft contact lenses	Commercially available silicone hydrogel contact lenses
DEVICE	Lotrafilcon B spherical soft contact lenses with comfort additive	Commercially available silicone hydrogel contact lenses
DEVICE	Lotrafilcon B toric soft contact lenses with comfort additive	Commercially available silicone hydrogel contact lenses
DEVICE	Comfilcon A spherical soft contact lenses	Commercially available silicone hydrogel contact lenses
DEVICE	Comfilcon A toric soft contact lenses	Commercially available silicone hydrogel contact lenses

Timeline

• Start date: 2023-08-03
• Primary completion: 2025-04-15
• Completion: 2025-04-15
• First posted: 2023-06-02
• Last updated: 2025-08-14

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study