Air Optix® Night and Day® Aqua Continuous Wear

Refractive Errors Clinical Trial

Official title: Air Optix® Night and Day® Aqua Continuous Wear

Status Enrolling by invitation

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Refractive Errors

• NCT number: NCT05992675
• Study type: Observational
• Source: Alcon Research
• Status: Enrolling by invitation
• Start date: October 5, 2023
• Completion date: July 2024