Air Optix® Night and Day® Aqua Daily Wear

Completed

• Conditions: Refractive Errors; Myopia; Hyperopia

• Registration Number: NCT05976750
• Lead Sponsor: Alcon Research

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.

Study Timeline

• Study First Submitted: 2023-07-26
• Study First Submitted QC: 2023-07-26
• Study First Posted: 2023-08-04
• Study Start: 2023-10-03
• Primary Completion: 2024-07-30
• Study Completion: 2024-07-30
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-07
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

• Normal eyes, as determined by the Investigator
• At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality
• Baseline and 1-year visit charts available
• Other protocol-specified inclusion criteria may apply

Exclusion Criteria

• Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline
• Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline
• History of refractive surgery or irregular cornea
• Other protocol-specified exclusion criteria may apply

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of microbial keratitis	Up to Year 1	The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.
Incidence of corneal infiltrative events	Up to Year 1	The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam.
Distance visual acuity by eye	Year 1	The subject's chart will be reviewed for distance visual acuity.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States