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AONDA Therapeutic Indication Study I

NCT05891106 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2023-07-20

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DEVICE

Lotrafilcon 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
2023-06-28
Primary Completion
2023-07-10
Completion
2023-07-10
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 NCT05891106 on ClinicalTrials.gov