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NCT04169061 · ClinicalTrials.gov registry record · Phase 4
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
A Phase 4 study of Keratitis, sponsored by Mallinckrodt.
- Completed
- Registry status
- Phase 4
- Development phase
- 36
- Enrollment target
- 9
- Study locations
NCT04169061: Completed Phase 4 study of Keratitis, sponsored by Mallinckrodt.
NCT04169061 is a Phase 4 study of Keratitis that has completed, run by Mallinckrodt. The registered enrollment target is 36 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). The trial reports 9 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04169061, a Phase 4 study of Keratitis, has completed, sponsored by Mallinckrodt.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 36 participants
- Enrollment target
- 9
- Study locations
Study Summary
We will need about 36 participants for this study. Volunteers might be able to participate if: * they have bad noninfectious keratitis * early treatments failed or were not well tolerated Participants will be in the study for about 22 weeks: * 4 weeks for tests to see if the study might be good for them * 12 weeks of treatment with Acthar gel * 4 weeks to wean off Acthar gel and follow-up with the doctor
Primary Outcome
A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.
Conditions Studied
Interventions
- DRUG Acthar
Study Locations (9)
California
- Global Research Management, Inc. - Glendale
- Eye Research Foundation - Newport Beach
Tennessee
- Total Eye Care, P.A. - Memphis
- Advancing Vision Research, LLC - Nashville
Arizona
- Cornea and Cataract Consultants of Arizona - Phoenix
Kentucky
- Eye Care Institute - Louisville
Massachusetts
- Andover Eye Associates - Raynham
North Carolina
- Vita Eye Clinic - Shelby
Pennsylvania
- Scott & Christie and Associates, PC - Cranberry Township
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-11-13 |
| Est. Completion | 2020-12-07 |
| Phase | Phase 4 |
What the finished NCT04169061 record still lists
NCT04169061 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Keratitis appearing as the primary indexed condition, and to 1 intervention - of which Acthar is the first listed.
NCT04169061 lists 9 locations in 7 states (California, Tennessee, Arizona).
Frequently Asked Questions
What is clinical trial NCT04169061 about?
NCT04169061 is a clinical study titled "Impact of Acthar on Everyday Life of Participants With Severe Keratitis". We will need about 36 participants for this study. Volunteers might be able to participate if: * they have bad noninfectious keratitis * early treatments failed or were not well tolerated Participants will be in the study for about 22 weeks: * 4 weeks for tests to see if the study might be good ...
What is the current status of trial NCT04169061?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 36 participants. The study started on 2019-11-13. Estimated completion is 2020-12-07.
What conditions does trial NCT04169061 study?
This clinical trial studies the following conditions: Keratitis.
What interventions are being tested in trial NCT04169061?
The interventions under investigation include: Acthar (DRUG).
Who is sponsoring clinical trial NCT04169061?
This trial is sponsored by Mallinckrodt, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04169061 being conducted?
This trial has 9 study locations across Arizona, California, Kentucky, Massachusetts, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Keratitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04169061's enrollment target sits among peer trials
36 1490th of 2000 higher than 495 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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