NCT05992675

Air Optix® Night and Day® Aqua Continuous Wear

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,256 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

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. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows: * 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 contact lens prescription for AONDA or PureVision 2 (PV2) was released. * The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed. The data collection period is defined as any approximately 3-year timeframe since and including 2009.

Conditions

• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Lotrafilcon A contact lenses	CE-marked silicone hydrogel contact lenses
DEVICE	Balafilcon A contact lenses	CE-marked silicone hydrogel contact lenses

Timeline

• Start date: 2023-10-05
• Primary completion: 2024-08-22
• Completion: 2024-08-22
• First posted: 2023-08-15
• Last updated: 2024-09-19

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated device study