Status:
RECRUITING
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Lead Sponsor:
Toyos Clinic
Conditions:
Autoimmune Diseases
Dry Eye
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief Summary
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 rece...
Detailed Description
The primary objective of the study is to demonstrate the on-label use of Acthar Gel with SelfJect for improvement of symptoms in non-infectious keratitis related to systemic autoimmune disease and the...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06964269
Start Date
February 11 2025
End Date
February 28 2028
Last Update
May 11 2025
Active Locations (1)
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1
Toyos Clinic
Nashville, Tennessee, United States, 37215