AONDA Therapeutic Indication Study I

Alcon

Status

Completed

Conditions

Corneal Edema

Corneal Erosion

Sicca Syndrome; Keratoconjunctivitis (Etiology)

Bullous Keratopathy

Bell Palsy

Foreign Body in Cornea

Keratoconjunctivitis

Entropion

Filamentary Keratitis

Corneal Ulcer

Corneal Dystrophy

Treatments

Device: Lotrafilcon A contact lenses

Study type

Observational

Funder types

Industry

Identifiers

NCT05891106

CLD265-P002

Details and patient eligibility

About

This study will be used to support assessment of AIR OPTIX® NIGHT & DAY® AQUA (AONDA) Soft Contact Lenses' safety and performance in accordance with updated European Union Medical Device Regulation (EU MDR) requirements.

Full description

In this retrospective observational study, the subject wore AONDA as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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