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NCT05956535 · ClinicalTrials.gov registry record
Air Optix® Night and Day® Aqua Therapeutic Wear
A clinical trial, sponsored by Alcon Research.
- Completed
- Registry status
- 168
- Enrollment target
NCT05956535: Completed study, sponsored by Alcon Research.
NCT05956535 is a clinical trial that has completed, run by Alcon Research. The registered enrollment target is 168 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05956535 has completed, sponsored by Alcon Research.
- COMPLETED
- Registry status
- 168 participants
- Enrollment target
Study 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.
Primary Outcome
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 exampl
Interventions
- DEVICE Balafilcon A contact lenses
- DEVICE Lotrafilcon A contact lenses
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2023-09-26 |
| Est. Completion | 2024-10-25 |
What the finished NCT05956535 record still lists
NCT05956535 is an observational study that tracks outcomes without assigning an intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 2 interventions - of which Balafilcon A contact lenses is the first listed.
NCT05956535 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05956535 about?
NCT05956535 is a clinical study titled "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.
What is the current status of trial NCT05956535?
This trial is currently completed. The enrollment target is 168 participants. The study started on 2023-09-26. Estimated completion is 2024-10-25.
What interventions are being tested in trial NCT05956535?
The interventions under investigation include: Balafilcon A contact lenses (DEVICE), Lotrafilcon A contact lenses (DEVICE).
Who is sponsoring clinical trial NCT05956535?
This trial is sponsored by Alcon Research, which has 275 total clinical trials registered on ClinicalTrials.gov.
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