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.
The primary objective of the study is to demonstrate the on-label use of Acthar Gel with SelfJect for improvement of symptoms in non-infectious keratitis related to systemic autoimmune disease and the improvement of the appearance and function of corneal nerves as visualized by confocal microscopy and demonstrated by Cochet-Bonnet) and to assess the improvement of common neuropathic corneal pain symptoms caused by dysfunctional nerves due to various autoimmune inflammatory disease. This study will also follow patients for up to 3 years after 12 weeks of administration of Acthar Gel 80 units twice weekly to assess changes from end of treatment to end of study in visual acuity, corneal and conjunctival staining
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Study intervention is twice weekly injections of Acthar Gel via single-dose pre-filled SelfJect injector for 12 weeks.
Toyos Clinic
Nashville, Tennessee, United States
RECRUITINGVisual 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
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
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
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
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