Air Optix Plus HydraGlyde Multifocal Daily/Extended Wear Contact Lenses

Alcon

Status: Invitation-only

Conditions: Refractive Errors

Treatments: Device: Lotrafilcon B multifocal soft contact lenses; Device: Comfilcon A multifocal soft contact lenses

Study type: Observational

Funder types: Industry

Identifiers

NCT05886894

CLJ241-N003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 340 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

340 participants in 4 patient groups

Air Optix plus HydraGlyde Multifocal Daily Wear

Description:

Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes and removed daily for cleaning and disinfection

Treatment:

Device: Lotrafilcon B multifocal soft contact lenses

Air Optix plus HydraGlyde Multifocal Extended Wear

Description:

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).

Treatment:

Device: Lotrafilcon B multifocal soft contact lenses

Biofinity Multifocal Daily Wear

Description:

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

Treatment:

Device: Comfilcon A multifocal soft contact lenses

Biofinity Multifocal Extended Wear

Description:

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).

Treatment:

Device: Comfilcon A multifocal soft contact lenses