Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

Alcon Research351 enrolled

Overview

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.

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

351

Conditions

Refractive Errors

Interventions

Lotrafilcon B multifocal soft contact lensesDEVICE

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

Comfilcon A multifocal soft contact lensesDEVICE

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

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

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.

Locations (8)

Complete Family Vision Care

San Diego, California, United States

Pearle Vision

Jacksonville, Florida, United States

Jackson Health Community Center

Miami, Florida, United States

Vision Health Institute

Orlando, Florida, United States

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: Year 3

Incidence of corneal infiltrative events - Daily Wear

Data from ClinicalTrials.gov

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