Actively Recruiting
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Led by Toyos Clinic · Updated on 2025-05-11
20
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to read, understand, and sign informed consent
- Willing to comply with all study procedures and available for study duration
- Male or female aged 18 to 85 years
- Normal eyelid anatomy
- Diagnosed with dry eye for at least 6 months prior to enrollment
- Symptom Bother score of 50.6 or greater at baseline
- Diagnosis of any autoimmune disease
- Presence of one or more corneal neuromas on baseline confocal microscopy
- Partial or total relief of corneal pain after one drop of proparacaine within 15 minutes
- No prior use of Acthar Gel or SelfJect for any indication
You will not qualify if you...
- Known hypersensitivity or contraindication to Acthar Gel or its components
- Unwillingness to participate in study activities or attend visits
- Current pregnancy or breastfeeding, or unwilling to use birth control during and 4 weeks after study
- Use of antihistamines, mast cell stabilizers, or prescription eye drops within 24 hours prior to screening unless stable for 14 days
- Current or recent (past 30 days) use of cenegermin, topical nerve growth factor, or platelet rich plasma
- Use of another investigational drug or intervention within 30 days prior to screening
- Serious or uncontrolled medical conditions that may affect study participation or safety
- Use of systemic medications that cause dry eye unless stable for at least 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Toyos Clinic
Nashville, Tennessee, United States, 37215
Actively Recruiting
Research Team
H
Harley cheney Study Coordinator, Study Coordinator
CONTACT
M
Melissa Toyos, MD, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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