NCT05956535

Air Optix® Night and Day® Aqua Therapeutic Wear

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 168 (actual)
• Sponsor: Alcon Research · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bullous Keratopathy
• Corneal Erosion
• Entropion
• Corneal Edema
• Corneal Dystrophy

Interventions

Type	Name	Description
DEVICE	Lotrafilcon A contact lenses	CE-marked silicone hydrogel contact lenses
DEVICE	Balafilcon A contact lenses	CE-marked silicone hydrogel contact lenses

Timeline

• Start date: 2023-09-26
• Primary completion: 2024-10-25
• Completion: 2024-10-25
• First posted: 2023-07-21
• Last updated: 2024-11-13

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study