Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

351 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-08

Study Completion Date

2025-06-20

Brief Summary

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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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Detailed Description

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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.

Conditions

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Refractive Errors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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

Lotrafilcon B multifocal soft contact lenses

Intervention Type DEVICE

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

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).

Lotrafilcon B multifocal soft contact lenses

Intervention Type DEVICE

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

Biofinity Multifocal Daily Wear

Comfilcon A multifocal soft contact lenses worn in both eyes and removed daily for cleaning and disinfection

Comfilcon A multifocal soft contact lenses

Intervention Type DEVICE

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

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).

Comfilcon A multifocal soft contact lenses

Intervention Type DEVICE

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

Interventions

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Lotrafilcon B multifocal soft contact lenses

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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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Air Optix plus HydraGlyde Multifocal Daily Wear Air Optix plus HydraGlyde Multifocal Extended Wear Biofinity Multifocal Daily Wear Biofinity Multifocal Extended Wear

Eligibility Criteria

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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;

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;

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No