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NCT06443775 · ClinicalTrials.gov registry record
An Observational Study to Assess Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED)
A clinical trial, sponsored by AbbVie.
- Completed
- Registry status
- 47
- Enrollment target
NCT06443775: Completed study, sponsored by AbbVie.
NCT06443775 is a clinical trial that has completed, run by AbbVie. The registered enrollment target is 47 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06443775 has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- 47 participants
- Enrollment target
Study Summary
Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) in adult participants with dry eye symptoms and who are high digital device users. NGE-UD is an over-the-counter (OTC) monograph drug indicated for the temporary relief of symptoms of eye dryness. Participants will administer 1 drop of NGE-UD on Day 1 for the acute phase of the study, after Day 1 participants will administer 1-2 eye drops in each eye at least twice a day but as much as needed through Day 15. Around 50 adult participants will be enrolled at one site in the United States. There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site as per standard of care.
Primary Outcome
The OSDI is a 12-question survey for patients to document their dry eye disease symptoms. The OSDI consists of a 5-point scale (0=none of the time to 4=all of the time), with higher scores representing greater disability. The scores are totaled over the 12 questions and converted to a score of 0-100 (0=no disability to 100=complete disability). A negative number change from baseline represents an improvement.
Interventions
- DRUG Next Generation Emulsion Preservative Free Eye Drops (NGE-UD)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2024-06-17 |
| Est. Completion | 2024-10-14 |
What the finished NCT06443775 record still lists
NCT06443775 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 47 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) is the first listed.
NCT06443775 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06443775 about?
NCT06443775 is a clinical study titled "An Observational Study to Assess Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) on Dry Eye Symptoms and Quality of Life of Adult Participants With Mild to Moderate Dry Eye Disease (DED)". Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) in adult particip...
What is the current status of trial NCT06443775?
This trial is currently completed. The enrollment target is 47 participants. The study started on 2024-06-17. Estimated completion is 2024-10-14.
What interventions are being tested in trial NCT06443775?
The interventions under investigation include: Next Generation Emulsion Preservative Free Eye Drops (NGE-UD) (DRUG).
Who is sponsoring clinical trial NCT06443775?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
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