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Air Optix® Night and Day® Aqua Therapeutic Wear

NCT05956535 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 168

Last updated 2024-11-13

No results posted yet for this study

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.

Conditions

  • Bullous Keratopathy
  • Corneal Erosion
  • Entropion
  • Corneal Edema
  • Corneal Dystrophy

Interventions

DEVICE

Lotrafilcon A contact lenses

CE-marked silicone hydrogel contact lenses

DEVICE

Balafilcon A contact lenses

CE-marked silicone hydrogel contact lenses

Sponsors & Collaborators

  • Alcon Research

    lead INDUSTRY

Principal Investigators

  • Clinical Trial Lead, CRD Vision Care · Alcon Research, LLC

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-26
Primary Completion
2024-10-25
Completion
2024-10-25
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05956535 on ClinicalTrials.gov