Repository Corticotropin Injection in Keratoconjunctivitis Sicca

• ClinicalTrials.gov Identifier: NCT03398018
• Recruitment Status: Withdrawn
• First Posted: January 12, 2018
• Last Update Posted: December 14, 2018
• Sponsor: University of Alabama at Birmingham
• Information provided by (Responsible Party): Jason Nichols, University of Alabama at Birmingham

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Keratoconjunctivitis Sicca	Drug: repository corticotropin injection	Phase 4

Detailed Description:

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Repository Corticotropin Injection in Patients With Severe and Recalcitrant Keratoconjunctivitis Sicca
• Actual Study Start Date: November 1, 2018
• Actual Primary Completion Date: November 1, 2018
• Actual Study Completion Date: November 1, 2018

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; Treated with repository corticotropin injection	Drug: repository corticotropin injection; 80 units twice per week as a subcutaneous injection; Other Name: HP Acthar Gel

Outcome Measures

Primary Outcome Measures :

1. Conjunctival hyperemia [ Time Frame: 16 weeks ]
   Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M
2. Corneal staining [ Time Frame: 16 weeks ]
   Change from baseline in corneal staining with fluorescein

Secondary Outcome Measures :

1. Patient symptoms [ Time Frame: 16 weeks ]
   Change from baseline in patient symptoms as measured by Ocular Surface Disease Index (OSDI)
2. Tear cytokine concentration [ Time Frame: 16 weeks ]
   Change from baseline in tear cytokine concentration as measured by Raybiotech Human Dry Eye Disease Array Q1

Other Outcome Measures:

1. Needle Fear [ Time Frame: 16 weeks ]
   Change from baseline in Needle Fear Survey

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Age ≥ 18 years
• Severe keratoconjunctivitis sicca (KCS) as defined by meeting at least three of the following in the same or both eye(s): (1) OSDI ≥ 33, (2) sum corneal staining with fluorescein of ≥ 5 in at least one eye, (3) MMP-9 concentration ≥ 40 ng/ml in at least one eye as measured by InflammaDry®, and (4) bulbar hyperemia of ≥ 2.0 in at least one eye as measured by the Oculus Keratograph® 5M
• Recalcitrant or intolerant to treatment with cyclosporine 0.05% ophthalmic emulsion (Restasis®) or lifitegrast 5% ophthalmic solution (Xiidra®)

Exclusion Criteria:

• Past or present history of: scleroderma, osteoporosis, systemic bacterial or fungal infection (including but not limited to tuberculosis), psychosis, ocular herpes simplex, peptic ulcer, congestive heart failure, diabetes mellitus, myasthenia gravis, hypothyroidism, liver cirrhosis, primary adrenocortical insufficiency or adrenocortical hyperfunction, central serous chorioretinopathy.
• Any corticosteroid use within 60 days of study enrollment
• Topical cyclosporine 0.05% ophthalmic emulsion (Restasis) or lifitegrast 5% ophthalmic solution (Xiidra) use within 60 days of study enrollment
• Recent surgery within 90 days
• Current uncontrolled, sustained hypertension
• Post-prandial blood glucose value of ≥ 140 mg/dl as measured at the baseline visit
• Sensitivity to proteins of porcine origin
• Anticipated administration of live or live attenuated vaccines during the course of the study
• Known sensitivity to steroid or complications from prior steroid use that subject is unwilling to tolerate
• Pregnancy (as assessed by urine hCG) or nursing
• Participation in a clinical trial involving a drug or device within the past 30 days
• Investigator discretion based upon medical history and/or opinion of ability to maintain protocol compliance

Contacts and Locations

Locations

United States, Alabama

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Sponsors and Collaborators

University of Alabama at Birmingham

Investigators

• Principal Investigator: Jason J Nichols, OD, MPH, PhD; University of Alabama at Birmingham

More Information

• Responsible Party: Jason Nichols, Principal Investigator, University of Alabama at Birmingham
• ClinicalTrials.gov Identifier: NCT03398018
• Other Study ID Numbers: F00000001
• First Posted: January 12, 2018
• Last Update Posted: December 14, 2018
• Last Verified: December 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jason Nichols, University of Alabama at Birmingham:

dry eye; corticotropin

Additional relevant MeSH terms:

Keratoconjunctivitis; Keratoconjunctivitis Sicca; Dry Eye Syndromes; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases; Adrenocorticotropic Hormone; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs