Use of Acthar Gel Single-Dose Pre-Filled SelfJectTM Injector in Patients With Moderate-Severe Keratitis and Autoimmune Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorToyos Clinic
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
1. Have a known hypersensitivity or contraindication to the investigational product or their components.
Trial design
Treatments tested in this trial
- Acthar Gel 80 UNT/ML Injectable Solution
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov