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

Inclusion Criteria

• 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.

Exclusion Criteria

• 1. Have a known hypersensitivity or contraindication to the investigational product or their components.

• Unwilling to participate in study activities or report for study visits. 3. Current pregnancy or lactation per self-report. Patients who are unwilling to use an effective method of birth control while participating in the study and for four weeks after the last dose of study drug is administered.

• Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening and for the study, unless the dose has been stable for 14 days.

• Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.

• Treatment with another investigational drug or other intervention within 30 days of screening.

• Have serious or severe disease or uncontrolled medical condition that in the judgement of the investigator could confound study assessments, limit compliance, or pose safety risks.

• Systemic medications known to cause dry eye should not be used including antimuscarinics, antihistamines, vitamin A analogs, antianxiety agents, and others unless stable for at least 30 days.