Air Optix® Night and Day® Aqua Therapeutic Wear

Alcon

Status: Completed

Conditions: Corneal Edema; Corneal Erosion; Bullous Keratopathy; Entropion; Corneal Dystrophy

Treatments: Device: Lotrafilcon A contact lenses; Device: Balafilcon A contact lenses

Study type: Observational

Funder types: Industry

Identifiers

NCT05956535

CLD265-N001

Details and patient eligibility

About

The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.

Full description

In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
• Baseline and Follow-up (up to 1 year from Baseline) charts available.
• Other protocol-defined inclusion criteria may apply.

Exclusion criteria

• Had a condition (pathological, behavioral, and/or situational) that contraindicated therapeutic CL wear or confounds study results during the data collection period.
• Used systemic or ocular medication that would confound study results during the data collection period.
• Other protocol-defined exclusion criteria may apply.

Trial design

168 participants in 2 patient groups

AONDA contact lenses

Description:

Lotrafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.

Treatment:

Device: Lotrafilcon A contact lenses

PV2 contact lenses

Description:

Balafilcon A contact lenses worn therapeutically as a bandage lens in a continuous wear (CW) modality (lenses worn continuously including overnight) as instructed by the eye care professional.

Treatment:

Device: Balafilcon A contact lenses