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Repository Corticotropin Injection in Keratoconjunctivitis Sicca

Primary Purpose

Keratoconjunctivitis Sicca

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
repository corticotropin injection
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconjunctivitis Sicca focused on measuring dry eye, corticotropin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Treated with repository corticotropin injection

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
January 2, 2018
Last Updated
December 12, 2018
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03398018
Brief Title
Repository Corticotropin Injection in Keratoconjunctivitis Sicca
Official Title
Efficacy of Repository Corticotropin Injection in Patients With Severe and Recalcitrant Keratoconjunctivitis Sicca
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Change of direction
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
Keywords
dry eye, corticotropin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Treated with repository corticotropin injection
Intervention Type
Drug
Intervention Name(s)
repository corticotropin injection
Other Intervention Name(s)
HP Acthar Gel
Intervention Description
80 units twice per week as a subcutaneous injection
Primary Outcome Measure Information:
Title
Conjunctival hyperemia
Description
Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M
Time Frame
16 weeks
Title
Corneal staining
Description
Change from baseline in corneal staining with fluorescein
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Patient symptoms
Description
Change from baseline in patient symptoms as measured by Ocular Surface Disease Index (OSDI)
Time Frame
16 weeks
Title
Tear cytokine concentration
Description
Change from baseline in tear cytokine concentration as measured by Raybiotech Human Dry Eye Disease Array Q1
Time Frame
16 weeks
Other Pre-specified Outcome Measures:
Title
Needle Fear
Description
Change from baseline in Needle Fear Survey
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason J Nichols, OD, MPH, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Repository Corticotropin Injection in Keratoconjunctivitis Sicca

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