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Completed

NCT Number: NCT05886894

Air Optix Plus HydraGlyde Multifocal Daily/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 plus HydraGlyde Multifocal soft contact lenses in a real-world setting when worn as daily wear or extended (overnight) wear.

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Key information

Conditions

Refractive Errors Eye Diseases

Age range

40 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, e.g., reviewing all eligible charts in reverse chronological order by year of baseline visit. The baseline visit will be 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 lenses was released. Subjects/charts meeting the eligibility criteria will be enrolled in the study.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
  • Must have worn or be wearing Air Optix plus Hydraglyde Multifocal or Biofinity Multifocal for at least 1 year in a daily wear modality, or 3 years in an extended wear modality;
  • 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;
  • Participation of the patient in a contact lens or contact lens care product trial during the period of the retrospective chart collection;
  • Other protocol-defined exclusion criteria may apply.

Treatment and study plan

Lotrafilcon B multifocal soft contact lenses

Device

Commercially available soft (hydrophilic) contact lenses indicated for the correction of presbyopia, with or without myopia or hyperopia

Other names: Air Optix plus HydraGlyde Multifocal Daily Wear, Air Optix plus HydraGlyde Multifocal Extended Wear

Comfilcon A multifocal soft contact lenses

Device

Commercially available soft (hydrophilic) contact lenses indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia

Other names: Biofinity Multifocal Daily Wear, Biofinity Multifocal Extended Wear

Primary outcomes

  1. Distance visual acuity at 1 year - Daily Wear

    Time frame: Year 1

    The subject's chart will be reviewed for distance visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).

  2. Near visual acuity at 1 year - Daily Wear

    Time frame: Year 1

    The subject's chart will be reviewed for near visual acuity at Year 1, defined as the visit which occurred 1 year (-2/+4 months) since baseline, during which period the subject was wearing the protocol required contact lenses and a contact lens examination was performed. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).

  3. Distance visual acuity at 3 years - Extended Wear

    Time frame: Year 3

    The subject's chart will be reviewed for distance visual acuity at Year 3, defined as the 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. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).

  4. Near visual acuity at 3 years - Extended Wear

    Time frame: Year 3

    The subject's chart will be reviewed for near visual acuity at Year 3, defined as the 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. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).

  5. Incidence of corneal infiltrative events - Daily Wear

    Time frame: Up to Year 1

    The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).

  6. Incidence of corneal infiltrative events - Extended Wear

    Time frame: Up to Year 3

    The subject's chart will be reviewed for incidences of corneal infiltrative events occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).

  7. Incidence of microbial keratitis - Daily Wear

    Time frame: Up to Year 1

    The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the daily wear arms (Air Optix plus HydraGlyde Multifocal Daily Wear and Biofinity Multifocal Daily Wear).

  8. Incidence of microbial keratitis - Extended Wear

    Time frame: Up to Year 3

    The subject's chart will be reviewed for incidences of microbial keratitis occurring after the baseline exam. This outcome measure is prespecified for the extended wear arms (Air Optix plus HydraGlyde Multifocal Extended Wear and Biofinity Multifocal Extended Wear).

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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