AONDA Therapeutic Indication Study I

Last updated: July 18, 2023
Sponsor: Alcon Research
Overall Status: Completed

Phase

N/A

Condition

Sjogren's Syndrome

Dermatomyositis (Connective Tissue Disease)

Eye Disorders/infections

Treatment

Lotrafilcon A contact lenses

Clinical Study ID

NCT05891106
CLD265-P002
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Key Inclusion Criteria:

  • Diagnosis of a corneal condition with pain for which AONDA Soft Contact Lens as atherapeutic 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.

Exclusion

Key Exclusion Criteria:

  • Had a condition (pathological, behavioral, and/or situational) that contraindicatedtherapeutic contact lens wear or confounds study results during the data collectionperiod, as determined or known by the Investigator.
  • Used systemic or ocular medication that would confound study results during the datacollection period, as determined or known by the Investigator.
  • Other protocol-defined exclusion criteria may apply.

Study Design

Total Participants: 55
Treatment Group(s): 1
Primary Treatment: Lotrafilcon A contact lenses
Phase:
Study Start date:
June 28, 2023
Estimated Completion Date:
July 10, 2023

Study Description

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.

Connect with a study center

  • Vision Health Institute

    Orlando, Florida 32803
    United States

    Site Not Available

  • Franklin Park Eye Center PC

    Franklin Park, Illinois 60131
    United States

    Site Not Available

  • Optometry Group, PLLC

    Memphis, Tennessee 38111
    United States

    Site Not Available

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