Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease

Single-site, open label pilot study of 20 autoimmune patients diagnosed with dry eye demonstrating via the proparacaine challenge some peripheral corneal pain component. At least 16 patients will receive and complete 12 weeks of 80 units of Acthar Gel to be injected subcutaneously twice weekly via Acthar Gel single-dose pre-filled SelfJectTM injector (SelfJect) to assess the effects on subjective sensation of ocular pain, conjunctival and corneal staining, in vivo assessments of corneal nerves as measured by confocal imaging, VAS scales of common neuropathic pain symptoms and comfort of SelfJect will be assessed.

NCT Number	NCT06964269
Lead Sponsor	Toyos Clinic
Conditions	Autoimmune Diseases, Dry Eye, Neurotrophic Keratitis
Enrollment	20 participants
Start Date	2025-02-11
Primary Completion	2028-02-28 (estimated)
Study Completion	2028-02-28 (estimated)
Updated on ClinicalTrials.gov	2025-05-11