Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Completed · Phase 4
Conditions studied: Keratitis
In brief
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
Key facts
- Study ID
- NCT04169061
- Run by
- Mallinckrodt
- People needed
- 36
- Starts
- 2019-11-13
- Expected to finish
- 2020-12-07
- Last updated by the study team
- 2021-08-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Has severe or recalcitrant keratitis
- Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
- If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
- Has normal eyelids, and protocol-defined physical and medical eye attributes
- Agrees to avoid wearing contact lenses during the trial
You may not qualify if…
- Is pregnant or breast-feeding
- Is defined as vulnerable, or is employed by, or related to anyone involved in the study
- Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis
Where it is running
- Cornea and Cataract Consultants of Arizona — Phoenix, Arizona, United States
- Global Research Management, Inc. — Glendale, California, United States
- Eye Research Foundation — Newport Beach, California, United States
- Eye Care Institute — Louisville, Kentucky, United States
- Andover Eye Associates — Raynham, Massachusetts, United States
- Vita Eye Clinic — Shelby, North Carolina, United States
- Scott & Christie and Associates, PC — Cranberry Township, Pennsylvania, United States
- Total Eye Care, P.A. — Memphis, Tennessee, United States
- Advancing Vision Research, LLC — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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