Repository Corticotropin Injection in Keratoconjunctivitis Sicca

Phase 4

Withdrawn

• Conditions: Keratoconjunctivitis Sicca
• Interventions: Drug: repository corticotropin injection

• Registration Number: NCT03398018
• Lead Sponsor: University of Alabama at Birmingham

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.

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 Timeline

• Study First Submitted: 2018-01-02
• Study First Submitted QC: 2018-01-05
• Study First Posted: 2018-01-12
• Study Start: 2018-11-01
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-12
• Last Update Posted: 2018-12-14

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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®)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	repository corticotropin injection	Treated with repository corticotropin injection

Primary Outcome Measures

Name	Time	Method
Conjunctival hyperemia	16 weeks	Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M
Corneal staining	16 weeks	Change from baseline in corneal staining with fluorescein

Secondary Outcome Measures

Name	Time	Method
Tear cytokine concentration	16 weeks	Change from baseline in tear cytokine concentration as measured by Raybiotech Human Dry Eye Disease Array Q1
Patient symptoms	16 weeks	Change from baseline in patient symptoms as measured by Ocular Surface Disease Index (OSDI)

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States