Air Optix® Night and Day® Aqua Therapeutic Wear

The purpose of this study is to support the safety and performance assessment of Air Optix Night and Day Aqua (AONDA) soft contact lenses for therapeutic use in accordance with updated EU Medical Device Regulation (MDR) requirements.

Completed

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Key information

Conditions

Bullous Keratopathy Congenital, Hereditary, and Neonatal Diseases and Abnormalities Corneal Diseases Corneal Dystrophies, Hereditary Corneal Dystrophy Corneal Edema Corneal Erosion Entropion Eye Diseases Eye Diseases, Hereditary Eyelid Diseases Genetic Diseases, Inborn

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Delray Physician Care Center, Delray Beach, Florida, United States

About this study

In this retrospective, real world evidence study, the subjects wore Air Optix Night and Day Aqua (AONDA) soft contact lenses or PureVision 2 (PV2) soft contact lenses as a therapeutic lens for the treatment of a corneal condition with pain in one or both eyes as part of their eye care professional's treatment and management plan.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Diagnosis of a corneal condition with pain for which AONDA or PV2 contact lenses were placed on one or both eye(s) as a therapeutic contact lens at Baseline.
Baseline and Follow-up (up to 1 year from Baseline) charts available.
Other protocol-defined inclusion criteria may apply.

Exclusion criteria

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

Treatment and study plan

Lotrafilcon A contact lenses

Device

CE-marked silicone hydrogel contact lenses

Other names: Air Optix® Night and Day® Aqua, AONDA

Balafilcon A contact lenses

Device

CE-marked silicone hydrogel contact lenses

Other names: PureVision® 2, PV2

Primary outcomes

Change from baseline in corneal pain at the Follow-up Visit - Primary exposure

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 therapeutic contact lens was placed on eye as part of a treatment plan for a corneal condition. The Follow-up Visit is defined as the first visit where the 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. The primary exposure is defined as the first exposure to the study lens if, for example, there were multiple exposures to the study lens. The data collection period consists of any timeframe since and including 2009.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Jul 21, 2023
Registry last updated: Nov 13, 2024

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