The purpose of this pilot study is to assess repository corticotropin injection (RCI) in the form of H.P. Acthar Gel in patients with severe keratoconjunctivitis sicca (KCS, or dry eye disease). This pilot study is a non-randomized, open-label, interventional study to assess the efficacy and timeline of RCI for the treatment of severe KCS recalcitrant to conventional therapy. The purpose is to acquire preliminary data to support and guide the design of a future, double-masked, randomized, controlled clinical trial.
This study is a non-randomized, open-label, interventional pilot study with sixteen weeks (112 days) of active treatment, a possible twelve-week treatment extension, and twenty-four weeks of washout follow-up. Intervention is with HP Acthar Gel dosed at 80 U BIW SC indicated for use in anterior segment disease and keratitis. Data will be collected from five subjects. All subjects will be treated with 80 U BIW SC and clinically examined at two, four, six, nine, twelve, and sixteen weeks with a potential extension of up to twenty-eight weeks. Extension will be contingent upon specific outcome criteria defined in this protocol. Four clinical visits will occur at two, four, eight, and twelve weeks after initiating the drug taper to assess for regression of the signs and symptoms of KCS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
80 units twice per week as a subcutaneous injection
University of Alabama at Birmingham
Birmingham, Alabama, United States
Conjunctival hyperemia
Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M
Time frame: 16 weeks
Corneal staining
Change from baseline in corneal staining with fluorescein
Time frame: 16 weeks
Patient symptoms
Change from baseline in patient symptoms as measured by Ocular Surface Disease Index (OSDI)
Time frame: 16 weeks
Tear cytokine concentration
Change from baseline in tear cytokine concentration as measured by Raybiotech Human Dry Eye Disease Array Q1
Time frame: 16 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.