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Completed

NCT Number: NCT05790928

Air Optix Night and Day Aqua (AONDA) Retrospective Study 1

The purpose of this study is to assess long term performance and safety of AONDA in a real world setting when worn as daily wear or continuous wear for vision correction. This study will be used to support AONDA's marketability in Europe and other locations.

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Key information

Conditions

Refractive Ametropia Eye Diseases Hyperopia Myopia Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tallahassee Eye Center, Tallahassee, Florida, United States

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About this study

In this retrospective observational study, the subject used AONDA for at least approximately 1 year in either a daily wear (DW) or continuous wear (CW) modality with monthly replacement. For the CW cohort only, 3-year data will be collected, if available.

Who can participate

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

Key Inclusion Criteria:

  • Normal eyes, as determined or known by the investigator;
  • Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
  • Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
  • At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
  • Baseline and 1-year visit chart available;
  • Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

  • Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline;
  • The use of systemic or ocular medications contraindicating regular contact lens wear at baseline;
  • History of refractive surgery or irregular cornea;
  • Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline;
  • Other protocol-specified exclusion criteria may apply.

Treatment and study plan

Lotrafilcon A spherical contact lenses

Device

CE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity

Other names: AIR OPTIX Night & Day AQUA, AONDA

Primary outcomes

  1. Distance visual acuity at Year 1 - DW Cohort

    Time frame: Year 1

    The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  2. Distance Visual Acuity at Year 1 - CW Cohort

    Time frame: Year 1

    The subject's chart will be reviewed for a distance visual acuity assessment at 1 year after the baseline exam. The 1-year visit will be defined as a visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing AONDA, and a contact lens examination was performed. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  3. Distance Visual Acuity at Year 3 - CW Cohort

    Time frame: Year 3

    The subject's chart will be reviewed for a distance visual acuity assessment at 3 years after the baseline exam. The 3-year visit will be defined as a visit which occurred 3 years (-2/+8 months) since baseline, during which period the subject was wearing AONDA and a contact lens examination was performed. The 3-year visit will be applicable only if the chart indicates the subject was wearing AONDA since baseline and 1-year.

  4. Incidence of Corneal Infiltrative Events up to Year 1 - DW Cohort

    Time frame: Up to Year 1

    The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  5. Incidence of Corneal Infiltrative Events up to Year 1 - CW Cohort

    Time frame: Up to Year 1

    The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  6. Incidence of Corneal Infiltrative Events Up to Year 3 - CW Cohort

    Time frame: Up to Year 3

    The subject's chart will be reviewed for corneal infiltrative adverse events occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  7. Incidence of Microbial Keratitis up to Year 1 - DW Cohort

    Time frame: Up to Year 1

    The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  8. Incidence of Microbial Keratitis up to Year 1 - CW Cohort

    Time frame: Up to Year 1

    The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

  9. Incidence of Microbial Keratitis up to Year 3 - CW Cohort

    Time frame: Up to Year 3

    The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. Baseline will be defined as the first office visit where the investigator provided an in-person office biomicroscopy exam to the patient, before or during which a contact lens prescription for AONDA was released.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

AONDA Retrospective Study 1

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 30, 2023
Registry last updated
May 25, 2023

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.

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