Air Optix® Night and Day® Aqua Daily Wear
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| AONDA contact lenses Lotrafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional |
Device: Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses for daily wear use
Other Names:
|
| PV2 contact lenses Balafilcon A contact lenses worn daily and removed at night for cleaning and disinfection as instructed by the eye care professional |
Device: Balafilcon A contact lenses
CE-marked silicone hydrogel contact lenses for daily wear use
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Distance visual acuity by eye [Year 1]
The subject's chart will be reviewed for distance visual acuity.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Normal eyes, as determined by the Investigator
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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
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Baseline and 1-year visit charts available
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Other protocol-specified inclusion criteria may apply
Exclusion Criteria
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Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline
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Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline
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History of refractive surgery or irregular cornea
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Other protocol-specified exclusion criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Contact Alcon Call Center for Trial Locations | Fort Worth | Texas | United States | 76134 |
Sponsors and Collaborators
- Alcon Research
Investigators
- Study Director: Clinical Trial Lead, CRD Vision Care, Alcon Research, LLC
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLD265-N002