NCT05790928

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

AONDA Retrospective Study 1

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed 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.

Conditions

• Refractive Ametropia
• Hyperopia
• Myopia

Interventions

Type	Name	Description
DEVICE	Lotrafilcon A spherical contact lenses	CE-marked silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia) in persons with minimal astigmatism that does not interfere with visual acuity

Timeline

• Start date: 2023-03-25
• Primary completion: 2023-03-31
• Completion: 2023-03-31
• First posted: 2023-03-30
• Last updated: 2023-05-25

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study