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

Launched by TOYOS CLINIC · May 8, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of Acthar Gel, a medication given by injection, on patients who have moderate to severe dry eye due to autoimmune diseases. The goal is to see if this treatment can help reduce eye pain and improve the overall health of the eye's surface. Participants will be given Acthar Gel twice a week for 12 weeks and will share their experiences about any changes in pain, comfort, and other symptoms related to their dry eyes.

To be eligible for the trial, participants must be between 18 and 85 years old, have been diagnosed with dry eye for at least six months, and have a specific level of discomfort due to their symptoms. They should also have a diagnosed autoimmune disease and certain findings in their eye exams. Throughout the study, participants will have regular check-ins to assess their eye health and how they feel. It's important to note that some individuals may not be able to participate due to specific health conditions or recent treatments. If you're interested in learning more or think you might qualify, please reach out to the study team for more details.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subject can read, understand, sign and informed consent.
• • 2. Provision of signed and dated informed consent form and HIPPA authorization.
• • 3. Stated willingness to comply with all study procedures and availability
• • 4. for the duration of the study
• • 5. Male or female aged 18-85 years.
• • 6. Normal eyelid anatomy
• • 7. Patients diagnosed with dry eye for at least 6 months prior to enrollment.
• • 8. Patients with Symptom Bother score at Baseline of 50.6 or greater.
• • 9. Patients with a diagnosis of any autoimmune disease.
• • 10. Patients with one or more corneal neuroma as seen on baseline confocal microscopy.
• • 11. Patients with partial or total relief of corneal pain with one drop of proparacaine over 15 minutes post-instillation.
• • 12. 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.
• • 2. 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.
• • 4. 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.
• • 5. Current use of cenegermin, topical nerve growth factor or platelet rich plasma or use within the past 30 days.
• • 6. Treatment with another investigational drug or other intervention within 30 days of screening.
• • 7. 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.
• • 8. 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.