CompletedNot Applicable

Air Optix® Night and Day® Aqua Therapeutic Wear

United States168 participantsStarted 2023-09-26

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline, Follow-up Visit (up to 1 year following the Baseline Visit)

Trial details

NCT IDNCT05956535

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-10-25

View on ClinicalTrials.gov More Bullous Keratopathy trials