NCT06964269 · Toyos Clinic
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
(MNK)
What this study 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. 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.
Where
- Nashville, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 11, 2025 · Source of record for eligibility and locations