Air Optix® Night and Day® Aqua Daily Wear

Alcon

Status: Completed

Conditions: Myopia; Refractive Errors; Hyperopia

Treatments: Device: Lotrafilcon A contact lenses; Device: Balafilcon A contact lenses

Study type: Observational

Funder types: Industry

Identifiers

NCT05976750

CLD265-N002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

102 participants in 2 patient groups

AONDA contact lenses

Description:

Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional

Treatment:

Device: Lotrafilcon A contact lenses

PV2 contact lenses

Description:

Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional

Treatment:

Device: Balafilcon A contact lenses