Air Optix Extended Wear Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors

Treatments: Device: Comfilcon A toric soft contact lenses; Device: Comfilcon A spherical soft contact lenses; Device: Lotrafilcon B spherical soft contact lenses with comfort additive; Device: Lotrafilcon B toric soft contact lenses with comfort additive; Device: Lotrafilcon B spherical soft contact lenses

Study type: Observational

Funder types: Industry

Identifiers

NCT05886881

CLJ241-N002

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 Aqua Sphere, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as 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. Subjects/charts meeting the eligibility criteria will be enrolled in the study. The data collection period is defined as any approximately 1-year to 3-year timeframe since the respective lens brand was prescribed.

Enrollment: 511 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline (sphere wearers only);
• Best corrected visual acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
• Must have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere or Biofinity Toric for at least 3 years in an extended wear modality, as determined by the Investigator;
• 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;
• Other protocol-defined exclusion criteria may apply.

Trial design

511 participants in 5 patient groups

Air Optix Aqua Sphere

Description:

Lotrafilcon B spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Treatment:

Device: Lotrafilcon B spherical soft contact lenses

Air Optix plus HydraGlyde Sphere

Description:

Lotrafilcon B multifocal soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Treatment:

Device: Lotrafilcon B spherical soft contact lenses with comfort additive

Air Optix plus HydraGlyde Toric

Description:

Lotrafilcon B toric soft contact lenses with comfort additive worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Treatment:

Device: Lotrafilcon B toric soft contact lenses with comfort additive

Biofinity Sphere

Description:

Comfilcon A spherical soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Treatment:

Device: Comfilcon A spherical soft contact lenses

Biofinity Toric

Description:

Comfilcon A toric soft contact lenses worn in both eyes on an extended wear basis. Extended wear is defined as up to 6 days continuous wear (including while sleeping/overnight).

Treatment:

Device: Comfilcon A toric soft contact lenses