AONDA Therapeutic Indication Study I

Corneal Ulcer Clinical Trial

Official title:

AONDA Therapeutic Indication Study I

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05891106
• Other study ID #: CLD265-P002
• Status: Completed
• Start date: June 28, 2023
• Est. completion date: July 10, 2023

Study information

• Verified date: July 2023
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: July 10, 2023
• Est. primary completion date: July 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bell Palsy
• Bullous Keratopathy
• Corneal Dystrophies, Hereditary
• Corneal Dystrophy
• Corneal Edema
• Corneal Erosion
• Corneal Ulcer
• Entropion
• Filamentary Keratitis
• Foreign Bodies
• Keratitis
• Keratoconjunctivitis
• Sjogren's Syndrome

Intervention

Device:
• Lotrafilcon A contact lenses
CE-marked silicone hydrogel contact lenses

Locations

Country	Name	City	State
United States	Franklin Park Eye Center PC	Franklin Park	Illinois
United States	Optometry Group, PLLC	Memphis	Tennessee
United States	Vision Health Institute	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in corneal pain at the Follow-up 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)