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

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Toyos Clinic
Study ID
NCT06964269
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Autoimmune Diseases
  • Dry Eye
  • Neurotrophic Keratitis

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Acthar Gel 80 UNT/ML Injectable Solution — DRUG
    Study intervention is twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks.

Study Details

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.

Key Dates

Start date
Feb 11, 2025
Status verified
May 2025
Primary completion
Feb 28, 2028
Completion
Feb 28, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Active Comparator: One study arm of approximately 20 active receiving and completing active, open-label interventions.
    One study arm of approximately 20 active receiving and completing active, open-label interventions.

Primary Outcome Measure

Visual Analog scale for injection comfort [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Toyos ClinicNashvilleTennessee37215
Marcella Garza
[email protected]
6153274015
Melissa toyos, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Nashville, TN

By research site
Toyos Clinic· Nashville, TN

Related Studies