RECRUITINGPhase 4INTERVENTIONAL
Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
A Phase 4 Pilot Study With Extension to Assess the Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease and the Effect on Corneal Nerves and Neuropathic Corneal Pain
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
1. Subject can read, understand, sign and willing to sign a consent form.
2. Provision of signed and dated willing to sign a consent form 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 conditions (where your immune system attacks your own body).
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.
Who Should NOT Join This Trial:
- 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.
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
DRUG
Acthar Gel 80 UNT/ML Injectable Solution
Study intervention is twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks.
Locations (1)
Toyos Clinic
Nashville, Tennessee, United States