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Trial · Interventional

WithdrawnPhase 4Registry data

Repository Corticotropin Injection in Keratoconjunctivitis Sicca

NCTNCT03398018 (opens ClinicalTrials.gov in a new tab)Other idF00000001
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Overview

Status
Withdrawn
Phase
Phase 4
Enrollment
0 participants (actual)
Sponsor
University of Alabama at Birmingham · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
1 Nov 2018
Primary completion
1 Nov 2018
Completion
1 Nov 2018
First posted
12 Jan 2018
Last update posted
14 Dec 2018
Conditions
Keratoconjunctivitis Sicca

Timeline

1 trial · 1 stopped early

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20182019
  1. Ph 4

    Repository Corticotropin Injection in Keratoconjunctivitis Sicca

    NCT03398018

    1 Nov 2018 to 1 Nov 2018

    Withdrawn

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • repository corticotropin injectionDrug

Arms1

  • Experimental

    Treatment

    Treated with repository corticotropin injection

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Conjunctival hyperemia

    Time frame · 16 weeks

    Registry description

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

  2. Corneal staining

    Time frame · 16 weeks

    Registry description

    Change from baseline in corneal staining with fluorescein

Secondary outcomes(2)

  1. Patient symptoms

    Time frame · 16 weeks

    Registry description

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

  2. Tear cytokine concentration

    Time frame · 16 weeks

    Registry description

    Change from baseline in tear cytokine concentration as measured by Raybiotech Human Dry Eye Disease Array Q1

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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