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Repository Corticotropin Injection in Keratoconjunctivitis Sicca

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Recruitment Status : Withdrawn (Change of direction)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

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.

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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

Resource links provided by the National Library of Medicine


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




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



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398018


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Jason J Nichols, OD, MPH, PhD University of Alabama at Birmingham
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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    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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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