Air Optix Night and Day Aqua (AONDA) Retrospective Study 1

Alcon

Status: Completed

Conditions: Myopia; Refractive Ametropia; Hyperopia

Treatments: Device: Lotrafilcon A spherical contact lenses

Study type: Observational

Funder types: Industry

Identifiers

NCT05790928

CLD265-P001

Details and patient eligibility

About

The purpose of this study is to assess long term performance and safety of AONDA in a real world setting when worn as daily wear or continuous wear for vision correction. This study will be used to support AONDA's marketability in Europe and other locations.

Full description

In this retrospective observational study, the subject used AONDA for at least approximately 1 year in either a daily wear (DW) or continuous wear (CW) modality with monthly replacement. For the CW cohort only, 3-year data will be collected, if available.

Enrollment: 108 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Normal eyes, as determined or known by the investigator;
• Manifest refraction cylinder less than or equal to 0.75 diopter (D) in each eye at baseline;
• Best Corrected Visual Acuity (BCVA) of 20/25 Snellen or better in each eye at baseline;
• At the time of the 1-year visit, subject was prescribed and wearing AONDA in both eyes in either a DW or CW modality for at least approximately 1 without changing modality;
• Baseline and 1-year visit chart available;
• Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

• Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at baseline;
• The use of systemic or ocular medications contraindicating regular contact lens wear at baseline;
• History of refractive surgery or irregular cornea;
• Slit lamp findings, including signs of pathological dry eye, that would contraindicate regular contact lens wear at baseline;
• Other protocol-specified exclusion criteria may apply.

Trial design

108 participants in 2 patient groups

AONDA DW

Description:

Lotrafilcon A contact lenses worn in a daily wear (DW) modality (lenses removed nightly for cleaning) for at least 1 year with monthly replacement.

Treatment:

Device: Lotrafilcon A spherical contact lenses

AONDA CW

Description:

Lotrafilcon A contact lenses worn in a continuous wear (CW) modality (lenses worn continuously including overnight) for at least 1 year with monthly replacement.

Treatment:

Device: Lotrafilcon A spherical contact lenses