A Phase 4 Pilot Study With Extension to Assess the Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease and the Effect on Corneal Nerves and Neuropathic Corneal Pain
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.
• Subject can read, understand, sign and informed consent.
• Provision of signed and dated informed consent form and HIPPA authorization.
• Stated willingness to comply with all study procedures and availability
• for the duration of the study
• Male or female aged 18-85 years.
• Normal eyelid anatomy
• Patients diagnosed with dry eye for at least 6 months prior to enrollment.
• Patients with Symptom Bother score at Baseline of 50.6 or greater.
• Patients with a diagnosis of any autoimmune disease.
⁃ Patients with one or more corneal neuroma as seen on baseline confocal microscopy.
⁃ Patients with partial or total relief of corneal pain with one drop of proparacaine over 15 minutes post-instillation.
⁃ No prior use of Acthar Gel SelfJect or otherwise for any indication.