Health TrialsbyHealthPanel

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

ConditionsAutoimmune DiseasesDry EyeNeurotrophic Keratitis
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

This trial accepts healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: One study arm of approximately 20 active receiving and completing active, open-label interventions.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual Analog scale for injection comfort

To assess the severity of injection comfort in the eyes. scale ranges from 0(none) - 100(severe)

Time frame
3 years
2

Visual Analog scale for burning

To assess the severity of burning in the eyes. scale ranges from 0(none) - 100(severe)

Time frame
3 years
3

Visual Analog scale for Stinging

To assess the severity of stinging in the eyes. scale ranges from 0(none) - 100(severe)

Time frame
3 years
4

Visual Analog scale for Light sensitivity

To assess the severity of light sensitivity in the eyes. scale ranges from 0(none) - 100(severe)

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Toyos Clinic

Lead sponsor

Source ClinicalTrials.gov
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