Air Optix® Night and Day® Aqua Therapeutic Wear

Completed

Conditions studied: Bullous Keratopathy, Corneal Erosion, Entropion, Corneal Edema, Corneal Dystrophy

In brief

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.

Key facts

Study ID

NCT05956535

Run by

Alcon Research

People needed

168

Starts

2023-09-26

Expected to finish

2024-10-25

Last updated by the study team

2024-11-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Delray Physician Care Center — Delray Beach, Florida, United States
• Koetting Associates — St Louis, Missouri, United States
• Contact Alcon Call Center For Trial Locations — Fort Worth, Texas, United States

Full record on ClinicalTrials.gov

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