Repository Corticotropin Injection in Keratoconjunctivitis Sicca

NCT ID: NCT03398018

Last Updated: 2018-12-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2018-11-01

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.

Conditions

Keratoconjunctivitis Sicca

Keywords

dry eye; corticotropin

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Treated with repository corticotropin injection

Group Type: EXPERIMENTAL

repository corticotropin injection

Intervention Type: DRUG

80 units twice per week as a subcutaneous injection

Interventions

repository corticotropin injection

80 units twice per week as a subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

HP Acthar Gel

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Jason Nichols

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason J Nichols, OD, MPH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F00000001

Identifier Type: -

Identifier Source: org_study_id