AONDA Therapeutic Indication Study I

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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AONDA Therapeutic Indication Study I

Conditions
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Bullous Keratopathy, Corneal Erosion, Entropion, Corneal Edema, Corneal Dystrophy, Corneal Ulcer, Foreign Body in Cornea, Bell Palsy, Keratoconjunctivitis, Filamentary Keratitis, Sicca Syndrome; Keratoconjunctivitis (Etiology)

Intervention / Treatment
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* Device: Lotrafilcon A contact lenses


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AONDA Therapeutic<br>Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional | Device: Lotrafilcon A contact lenses<br>* CE-marked silicone hydrogel contact lenses<br>* Other names: AIR OPTIX® NIGHT & DAY® AQUA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit) |