RECRUITING

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

Conditions

Autoimmune Diseases Dry Eye Neurotrophic Keratitis Dry eye, autoimmune, Sjogren's, neurotrophic keratitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-02-11

Study Completion:2028-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06964269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Harley cheney Study Coordinator, Study Coordinator

CONTACT

+616153274015

hcheney@toyosclinic.com

Melissa Toyos, MD, MD

CONTACT

6153274015

mtoyos@toyosclinic.com

Study Locations (Sites)

Toyos Clinic

Nashville, Tennessee, 37215

United States

Collaborators and Investigators

Sponsor: Toyos Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-11

Study Completion Date2028-02-28

Study Record Updates

Study Start Date2025-02-11

Study Completion Date2028-02-28

Terms related to this study

Keywords Provided by Researchers

Dry eye, autoimmune, Sjogren's, neurotrophic keratitis

Additional Relevant MeSH Terms

Autoimmune Diseases
Dry Eye
Neurotrophic Keratitis