Impact of Acthar on Everyday Life of Participants With Severe Keratitis

A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects 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 for them
• 12 weeks of treatment with Acthar gel
• 4 weeks to wean off Acthar gel and follow-up with the doctor

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