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NCT04030962 · ClinicalTrials.gov registry record · Phase 1
A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease
A Phase 1 study, sponsored by AbbVie.
- Completed
- Registry status
- Phase 1
- Development phase
- 292
- Enrollment target
NCT04030962: Completed Phase 1 study, sponsored by AbbVie.
NCT04030962 is a Phase 1 study that has completed, run by AbbVie. The registered enrollment target is 292 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (387% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04030962, a Phase 1 study, has completed, sponsored by AbbVie.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 292 participants
- Enrollment target
Study Summary
This was a 2-stage study in which Stage 1 evaluated the safety of AGN-242428 and AGN-231868, how well they are tolerated, and how they move through the body when administered. After the sponsor's determination of adequate safety and tolerability of the interventions in Stage 1, Stage 2 began. Stage 2 also evaluated the safety and tolerability of AGN-242428 and AGN-231868, how effective they are in treating dry eye disease (DED), and assessed the plasma and tear exposure of both ophthalmic solutions.
Primary Outcome
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Interventions
- DRUG Lifitegrast 5% Ophthalmic Solution
- DRUG AGN-242428
- DRUG AGN-231868
- OTHER AGN-242428 Vehicle
- OTHER AGN-231868 Vehicle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2020-03-04 |
| Est. Completion | 2022-03-18 |
| Phase | Phase 1 |
What the finished NCT04030962 record still lists
NCT04030962 is an interventional study that assigns participants to a tested intervention. The registered 292 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (387% higher).
The record links to 0 conditions, and to 5 interventions - of which Lifitegrast 5% Ophthalmic Solution is the first listed.
NCT04030962 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04030962 about?
NCT04030962 is a clinical study titled "A Study of the Drugs AGN-242428 and AGN-231868 in Participants With Dry Eye Disease". This was a 2-stage study in which Stage 1 evaluated the safety of AGN-242428 and AGN-231868, how well they are tolerated, and how they move through the body when administered. After the sponsor's determination of adequate safety and tolerability of the interventions in Stage 1, Stage 2 began. Stage ...
What is the current status of trial NCT04030962?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 292 participants. The study started on 2020-03-04. Estimated completion is 2022-03-18.
What interventions are being tested in trial NCT04030962?
The interventions under investigation include: Lifitegrast 5% Ophthalmic Solution (DRUG), AGN-242428 (DRUG), AGN-231868 (DRUG), AGN-242428 Vehicle (OTHER), AGN-231868 Vehicle (OTHER).
Who is sponsoring clinical trial NCT04030962?
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 NCT04030962's enrollment target sits among peer trials
292 136th of 2000 higher than 1,864 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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