Air Optix® Night and Day® Aqua Daily Wear

Completed

• Conditions: Refractive Errors; Myopia; Hyperopia
• Interventions: Device: Lotrafilcon A contact lenses; Device: Balafilcon A contact lenses

• 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

Arm && Interventions

Group	Intervention	Description
AONDA contact lenses	Lotrafilcon A contact lenses	Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional
PV2 contact lenses	Balafilcon A contact lenses	Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional

Primary Outcome Measures

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

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