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OpenTrials
Completed

NCT Number: NCT05992675

Air Optix® Night and Day® Aqua Continuous Wear

The purpose of this retrospective, Post-Market Clinical Follow-Up (PMCF) study is to assess the long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as 30 days of continuous wear for vision correction.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Complete Family Vision Care, San Diego, California, United States

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About this study

This is a non-interventional/observational study designed as a retrospective chart review. Study sites will identify charts within their existing databases in a fair and consistent manner. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

The study is designed with one period. The duration of the period includes the Baseline Visit and the Year 3 Visit as follows:

  • The Baseline Visit is defined as the first office visit where an eye care professional provided an in-person office biomicroscopy exam to the subject, before or during which a contact lens prescription for AONDA or PureVision 2 (PV2) was released.
  • The Year 3 Visit is defined as a visit which occurred 3 years (-2/+8 months) since Baseline during which period the subject was wearing AONDA contact lenses or PV2 contact lenses and a contact lens examination was performed.

The data collection period is defined as any approximately 3-year timeframe since and including 2009.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Manifest refraction cylinder less than or equal to 0.75 diopter in each eye at baseline
  • Best corrected visual acuity of 20/25 or better in each eye at baseline
  • At the time of Year 3 Visit, subject was prescribed and wearing AONDA or PV2 contact lenses in both eyes in a 30-day continuous wear modality for at least approximately 3 years
  • Baseline Visit and Year 3 Visit charts available

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

Treatment and study plan

Lotrafilcon A contact lenses

Device

CE-marked silicone hydrogel contact lenses

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

Balafilcon A contact lenses

Device

CE-marked silicone hydrogel contact lenses

Other names: PureVision® 2, PV2

Primary outcomes

  1. Distance visual acuity

    Time frame: Year 3

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

  2. Incidence of corneal infiltrative events

    Time frame: Up to Year 3

    The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the Baseline Visit exam.

  3. Incidence of microbial keratitis

    Time frame: Up to Year 3

    The subject's chart will be reviewed for incidences of microbial keratitis occurring after the Baseline Visit 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 15, 2023
Registry last updated
Sep 19, 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.

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