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Completed

NCT Number: NCT05886881

Air Optix Extended Wear Contact Lenses

The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as extended (overnight) wear.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vision Health Institute, Orlando, Florida, 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, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);
  • Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
  • Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 3 years in an extended wear modality, as determined by the Investigator;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

  • Any recurrent history or active anterior segment infection, inflammation or abnormality contraindicating regular contact lens wear at baseline;
  • Use of systemic or ocular medications contraindicating regular contact lens wear at baseline and/or during the period of the retrospective chart collection;
  • Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B spherical soft contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: Air Optix® Aqua Sphere

Lotrafilcon B spherical soft contact lenses with comfort additive

Device

Commercially available silicone hydrogel contact lenses

Other names: Air Optix® plus HydraGlyde® Sphere

Lotrafilcon B toric soft contact lenses with comfort additive

Device

Commercially available silicone hydrogel contact lenses

Other names: Air Optix® plus HydraGlyde® Toric

Comfilcon A spherical soft contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: Biofinity Sphere

Comfilcon A toric soft contact lenses

Device

Commercially available silicone hydrogel contact lenses

Other names: Biofinity Toric

Primary outcomes

  1. Distance visual acuity (VA) with study lenses at Year 1

    Time frame: Year 1

    The subject's chart will be reviewed for distance visual acuity at Year 1, defined as a visit which occurred 1 year (-2/+4 months) since baseline during which period the subject was wearing either the study or comparator lenses and a contact lens examination was performed. The Baseline visit is defined as the first office visit where an eye care practitioner provided an in-person office biomicroscopy exam to the patient before or during which a contact lens prescription for the study or comparator contact lens (lotrafilcon B or comfilcon A) was released.

  2. Distance visual acuity (VA) with study lenses at Year 3

    Time frame: Year 3

    The subject's chart will be reviewed for distance visual acuity at Year 3, defined as a visit which occurred 3 years (-2/+8 months) since baseline during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed.

  3. 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 exam.

  4. 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 exam.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2023
Registry last updated
Aug 14, 2025

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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