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

NCT06964269 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-05-11

No results posted yet for this study

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 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

Interventions

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.

Sponsors & Collaborators

  • Toyos Clinic

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-11
Primary Completion
2028-02-28
Completion
2028-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06964269 on ClinicalTrials.gov