Air Optix Daily Wear Contact Lenses

Alcon

Status: Completed

Conditions: Refractive Errors

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05827224

CLJ241-N001

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, Air Optix plus HydraGlyde Sphere, and Air Optix plus HydraGlyde Toric soft contact lenses in a real-world setting when worn as daily 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 meeting the eligibility criteria will be enrolled in the study.

Enrollment: 312 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 1 year in a daily wear modality, as determined by the Investigator;
• Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

• Have worn or be wearing Air Optix Aqua Sphere, Air Optix plus HydraGlyde Sphere, Air Optix plus HydraGlyde Toric, Biofinity Sphere, or Biofinity Toric contact lenses in an extended wear modality;
• 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

312 participants in 5 patient groups

Air Optix Aqua Sphere

Description:

Lotrafilcon B spherical soft contact lenses worn in both eyes and removed daily for cleaning and disinfection

Treatment:

Device: Lotrafilcon B spherical soft contact lenses

Air Optix plus HydraGlyde Sphere

Description:

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

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 and removed daily for cleaning and disinfection

Treatment:

Device: Lotrafilcon B toric soft contact lenses with comfort additive

Biofinity Sphere

Description:

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

Treatment:

Device: Comfilcon A spherical soft contact lenses

Biofinity Toric

Description:

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

Treatment:

Device: Comfilcon A toric soft contact lenses