AONDA Therapeutic Indication Study I

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.

Completed

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Key information

Conditions

Bullous Keratopathy Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bell Palsy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conjunctival Diseases Conjunctivitis Connective Tissue Diseases Corneal Diseases Corneal Dystrophies, Hereditary Corneal Dystrophy Corneal Edema Corneal Erosion Corneal Ulcer Cranial Nerve Diseases DNA Virus Infections Dry Eye Syndromes Entropion Eye Diseases Eye Diseases, Hereditary Eye Infections Eyelid Diseases Facial Nerve Diseases Filamentary Keratitis Foreign Body in Cornea Genetic Diseases, Inborn Herpesviridae Infections Immune System Diseases Infections Joint Diseases Keratitis Keratoconjunctivitis Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Nervous System Diseases Rheumatic Diseases Salivary Gland Diseases Sicca Syndrome; Keratoconjunctivitis (Etiology) Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Virus Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vision Health Institute, Orlando, Florida, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lotrafilcon A contact lenses

Device

CE-marked silicone hydrogel contact lenses

Other names: AONDA, AIR OPTIX® NIGHT & DAY® AQUA

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Jun 6, 2023
Registry last updated: Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed