AONDA Therapeutic Indication Study I

July 18, 2023 updated by: Alcon Research
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32803
        • Vision Health Institute
    • Illinois
      • Franklin Park, Illinois, United States, 60131
        • Franklin Park Eye Center PC
    • Tennessee
      • Memphis, Tennessee, United States, 38111
        • Optometry Group, PLLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Investigators will enroll charts following a pre-identified process.

Description

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AONDA Therapeutic
Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional
Device: Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses
Other Names:
  • AONDA
  • AIR OPTIX® NIGHT & DAY® AQUA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in corneal pain at the Follow-up Visit
Time Frame: Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)
The Investigator will review the subject's chart and document change from baseline in corneal pain at the Follow-up visit as "improved, similar, or worsened." The Baseline Visit is defined as the first visit where the AONDA therapeutic contact lens was placed on eye as part of a treatment plan for an ocular condition. The Follow-up Visit is defined as the first visit where the AONDA therapeutic contact lens was removed from the eye, or the first visit following the removal of the contact lens if, for example, the contact lens was removed between visits.
Baseline, Follow-Up Visit (up to 1 year following the Baseline Visit)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alcon Research

Investigators

  • Study Director: Clinical Trial Lead, CRD Vision Care, Alcon Research, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 28, 2023

Primary Completion (Actual)

July 10, 2023

Study Completion (Actual)

July 10, 2023

Study Registration Dates

First Submitted

May 24, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

June 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 20, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLD265-P002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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