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.

Study Overview

• Status: Completed
• Conditions: Refractive Errors
• Intervention / Treatment: Device: Lotrafilcon B multifocal soft contact lenses; Device: Comfilcon A multifocal soft contact lenses

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 351

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92123
      • Complete Family Vision Care
  • Florida
    • Jacksonville, Florida, United States, 32246
      • Pearle Vision
    • Miami, Florida, United States, 33126
      • Jackson Health Community Center
    • Orlando, Florida, United States, 32803
      • Vision Health Institute
  • Minnesota
    • Medina, Minnesota, United States, 55340
      • Complete Eye Care of Medina
  • Missouri
    • Saint Louis, Missouri, United States, 63144
      • Koetting Associates
  • New York
    • Vestal, New York, United States, 13850
      • Sacco Eye Group
  • Utah
    • Salt Lake City, Utah, United States, 84117
      • Smith Bowman Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Air Optix plus HydraGlyde Multifocal Daily Wear; Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection	Device: Lotrafilcon B multifocal soft contact lenses; 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
Air Optix plus HydraGlyde Multifocal Extended Wear; Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes worn on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).	Device: Lotrafilcon B multifocal soft contact lenses; 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
Biofinity Multifocal Daily Wear; Comfilcon A multifocal soft contact lenses worn in both eyes and removed daily for cleaning and disinfection	Device: Comfilcon A multifocal soft contact lenses; 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
Biofinity Multifocal Extended Wear; Comfilcon A multifocal soft contact lenses worn in both eyes worn on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).	Device: Comfilcon A multifocal soft contact lenses; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance visual acuity at 1 year - Daily Wear	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).	Year 1
Near visual acuity at 1 year - Daily Wear	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).	Year 1
Distance visual acuity at 3 years - Extended Wear	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).	Year 3
Near visual acuity at 3 years - Extended Wear	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).	Year 3
Incidence of corneal infiltrative events - Daily Wear	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).	Up to Year 1
Incidence of corneal infiltrative events - Extended Wear	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).	Up to Year 3
Incidence of microbial keratitis - Daily Wear	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).	Up to Year 1
Incidence of microbial keratitis - Extended Wear	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).	Up to Year 3

Collaborators and Investigators

• Sponsor: Alcon Research
• Investigators: Study Director: Clinical Trial Lead, Vision Care, Alcon Research, LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2023
• Primary Completion (Actual): June 20, 2025
• Study Completion (Actual): June 20, 2025

Study Registration Dates

• First Submitted: May 24, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 2, 2023

Study Record Updates

• Last Update Posted (Actual): August 14, 2025
• Last Update Submitted That Met QC Criteria: August 12, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CLJ241-N003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No