NCT05976750

Air Optix® Night and Day® Aqua Daily Wear

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 102 (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® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.

Detailed description

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009. The anticipated duration of the study is approximately 6 months.

Conditions

• Refractive Errors
• Myopia
• Hyperopia

Interventions

Type	Name	Description
DEVICE	Lotrafilcon A contact lenses	CE-marked silicone hydrogel contact lenses for daily wear use
DEVICE	Balafilcon A contact lenses	CE-marked silicone hydrogel contact lenses for daily wear use

Timeline

• Start date: 2023-10-03
• Primary completion: 2024-07-30
• Completion: 2024-07-30
• First posted: 2023-08-04
• Last updated: 2024-08-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study