AONDA Therapeutic Indication Study I

Alcon Research55 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Bullous Keratopathy Corneal Erosion Entropion Corneal Edema Corneal Dystrophy Corneal Ulcer Foreign Body in Cornea Bell Palsy

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (3)

Vision Health Institute

Orlando, Florida, United States

Franklin Park Eye Center PC

Franklin Park, Illinois, United States

Optometry Group, PLLC

Memphis, Tennessee, United States

Outcomes

Primary Outcomes

Change from baseline in corneal pain at the Follow-up Visit

The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits.

Time frame: Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)

Data from ClinicalTrials.gov

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