Repository Corticotropin Injection in Keratoconjunctivitis Sicca

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03398018
Collaborator
(none)
0
1
1

Study Details

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
  • 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
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 :
Nov 1, 2018
Actual Primary Completion Date :
Nov 1, 2018
Actual Study Completion Date :
Nov 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 Names:
  • HP Acthar Gel
  • Outcome Measures

    Primary Outcome Measures

    1. Conjunctival hyperemia [16 weeks]

      Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M

    2. Corneal staining [16 weeks]

      Change from baseline in corneal staining with fluorescein

    Secondary Outcome Measures

    1. Patient symptoms [16 weeks]

      Change from baseline in patient symptoms as measured by Ocular Surface Disease Index (OSDI)

    2. Tear cytokine concentration [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 [16 weeks]

      Change from baseline in Needle Fear Survey

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jason Nichols, Principal Investigator, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT03398018
    Other Study ID Numbers:
    • F00000001
    First Posted:
    Jan 12, 2018
    Last Update Posted:
    Dec 14, 2018
    Last Verified:
    Dec 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    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, Principal Investigator, University of Alabama at Birmingham
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 14, 2018