Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

NCT05886894 | Completed FDA Device

• 1 other identifier: CLJ241-N003
• Study Type: observational
• Target: 351
• Locations: 1 country
• Sites: 8

Brief Summary

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.

Conditions

Refractive Errors

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (4)

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

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

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

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

Interventions

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

Also known as: Air Optix plus HydraGlyde Multifocal Daily Wear, Air Optix plus HydraGlyde Multifocal Extended Wear

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

Also known as: Biofinity Multifocal Daily Wear, Biofinity Multifocal Extended Wear

Biofinity Multifocal Daily Wear; Biofinity Multifocal Extended Wear

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Alcon Research: lead

Study Sites (8)

Complete Family Vision Care

San Diego, California, 92123, United States

Location

Pearle Vision

Jacksonville, Florida, 32246, United States

Location

Jackson Health Community Center

Miami, Florida, 33126, United States

Location

Vision Health Institute

Orlando, Florida, 32803, United States

Location

Complete Eye Care of Medina

Medina, Minnesota, 55340, United States

Location

Koetting Associates

St Louis, Missouri, 63144, United States

Location

Sacco Eye Group

Vestal, New York, 13850, United States

Location

Smith Bowman Ophthalmology

Salt Lake City, Utah, 84117, United States

Location

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Clinical Trial Lead, Vision Care

  Alcon Research, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 2, 2023
• Study Start: August 8, 2023
• Primary Completion: June 20, 2025
• Study Completion: June 20, 2025
• Last Updated: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)