AONDA Therapeutic Indication Study I

Completed

• Conditions: Corneal Ulcer; Bell Palsy; Keratoconjunctivitis; Foreign Body in Cornea; Corneal Erosion; Corneal Edema; Corneal Dystrophy; Sicca Syndrome; Keratoconjunctivitis (Etiology); Bullous Keratopathy; Filamentary Keratitis
• Interventions: Device: Lotrafilcon A contact lenses

• Registration Number: NCT05891106
• Lead Sponsor: Alcon Research

Brief 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.

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 Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-06-06
• Study Start: 2023-06-28
• Status Verified: 2023-07
• Primary Completion: 2023-07-10
• Study Completion: 2023-07-10
• Last Update Submitted: 2023-07-18
• Last Update Posted: 2023-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AONDA Therapeutic	Lotrafilcon A contact lenses	Lotrafilcon A contact lenses worn therapeutically as a bandage lens as instructed by the eye care professional

Primary Outcome Measures

Name	Time	Method
Change from baseline in corneal pain at the Follow-up Visit	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.

Trial Locations

Locations (3)

Vision Health Institute; 🇺🇸 Orlando, Florida, United States

Franklin Park Eye Center PC; 🇺🇸 Franklin Park, Illinois, United States

Optometry Group, PLLC; 🇺🇸 Memphis, Tennessee, United States