Air Optix® Night and Day® Aqua Daily Wear
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Refractive Errors
- Sponsor
- Alcon Research
- Enrollment
- 102
- Locations
- 1
- Primary Endpoint
- Incidence of corneal infiltrative events
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of corneal infiltrative events
Time Frame: 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
Time Frame: Year 1
The subject's chart will be reviewed for distance visual acuity.
Incidence of microbial keratitis
Time Frame: Up to Year 1
The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam.