Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-29 @ 7:26 PM
Study NCT ID:
NCT05976750
Status:
COMPLETED
Last Update Posted:
2024-08-09
First Post:
2023-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Air Optix® Night and Day® Aqua Daily Wear
Sponsor:
Alcon Research
Organization:
Study Overview
Official Title:
Air Optix® Night and Day® Aqua Daily Wear
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
The anticipated duration of the study is approximately 6 months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: