Impact of Acthar on Everyday Life of Participants With Severe Keratitis

• Status: Completed
• Trial end date: 2020-12-07
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mallinckrodt
• Treatments: Adrenocorticotropic Hormone

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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