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NCT05878067 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants
A Phase 3 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 3
- Development phase
- 40
- Enrollment target
NCT05878067: Completed Phase 3 study, sponsored by AbbVie.
NCT05878067 is a Phase 3 study that has completed, run by AbbVie. The registered enrollment target is 40 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05878067, a Phase 3 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 40 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 symptom relief and tolerability of ABBV-444 eye drops in adult participants. ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). This is a 30-day, open-label study to evaluate adult participant symptoms and tolerability of ABBV-444. Around 40 participants will be enrolled in 1 site in the United States. Participants will receive 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Primary Outcome
The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.
Interventions
- DRUG ABBV-444
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2023-10-06 |
| Phase | Phase 3 |
What the finished NCT05878067 record still lists
NCT05878067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which ABBV-444 is the first listed.
NCT05878067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05878067 about?
NCT05878067 is a clinical study titled "A Study to Assess Symptom Relief and Product Tolerability of ABBV-444 Drops in Adult Participants". 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 symptom relief and tolerability of ABBV-444 eye drops in adult participants. A...
What is the current status of trial NCT05878067?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 40 participants. The study started on 2023-06-27. Estimated completion is 2023-10-06.
What interventions are being tested in trial NCT05878067?
The interventions under investigation include: ABBV-444 (DRUG).
Who is sponsoring clinical trial NCT05878067?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05878067's enrollment target sits among peer trials
40 1878th of 2000 higher than 103 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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