NCT05827224

Air Optix Daily Wear Contact Lenses

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 312 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as daily 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 meeting the eligibility criteria will be enrolled in the study.

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: 2023-08-02
• Primary completion: 2024-07-17
• Completion: 2024-07-17
• First posted: 2023-04-24
• Last updated: 2024-08-15

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated device study