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Air Optix® Night and Day® Aqua Daily Wear

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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

Trial contacts and locations

1

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Central trial contact

Alcon Call Center

Data sourced from clinicaltrials.gov

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