A Phase 4 interventional study of repository corticotropin injection in Keratoconjunctivitis Sicca, sponsored by University of Alabama at Birmingham. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-12-14.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
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.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
Browse Keratoconjunctivitis Sicca studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treated with repository corticotropin injection
Drug: repository corticotropin injection
80 units twice per week as a subcutaneous injection
Also known as: HP Acthar Gel
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
Needle Fear
Change from baseline in Needle Fear Survey
Time frame: 16 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Nov 2018 to primary completion in Nov 2018, 0 months.
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This study is withdrawn, as verified in Dec 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Adrenocorticotropic Hormone
University of Alabama at Birmingham →