Skip to main content
OpenTrials
Completed

NCT Number: NCT05976750

Air Optix® Night and Day® Aqua Daily Wear

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lotrafilcon A contact lenses

Device

CE-marked silicone hydrogel contact lenses for daily wear use

Other names: AONDA, Air Optix® Night and Day® Aqua

Balafilcon A contact lenses

Device

CE-marked silicone hydrogel contact lenses for daily wear use

Other names: PV2, PureVision® 2

Primary outcomes

  1. Distance visual acuity by eye

    Time frame: Year 1

    The subject's chart will be reviewed for distance visual acuity.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 4, 2023
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.