Trials / Completed
CompletedNCT05891106
AONDA Therapeutic Indication Study I
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 55 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
- Bullous Keratopathy
- Corneal Erosion
- Entropion
- Corneal Edema
- Corneal Dystrophy
- Corneal Ulcer
- Foreign Body in Cornea
- Bell Palsy
- Keratoconjunctivitis
- Filamentary Keratitis
- Sicca Syndrome; Keratoconjunctivitis (Etiology)
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Lotrafilcon A contact lenses | CE-marked silicone hydrogel contact lenses |
Timeline
- Start date
- 2023-06-28
- Primary completion
- 2023-07-10
- Completion
- 2023-07-10
- First posted
- 2023-06-06
- Last updated
- 2023-07-20
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05891106. Inclusion in this directory is not an endorsement.