Repository Corticotropin Injection in Keratoconjunctivitis Sicca

Keratoconjunctivitis Sicca Clinical Trial

Official title:

Efficacy of Repository Corticotropin Injection in Patients With Severe and Recalcitrant Keratoconjunctivitis Sicca

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03398018
• Other study ID #: F00000001
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 1, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: December 2018
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis
• Keratoconjunctivitis Sicca

Intervention

Drug:
• repository corticotropin injection
80 units twice per week as a subcutaneous injection

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Needle Fear	Change from baseline in Needle Fear Survey	16 weeks
Primary	Conjunctival hyperemia	Change from baseline in bulbar conjunctival hyperemia as measured by the Oculus Keratograph 5M	16 weeks
Primary	Corneal staining	Change from baseline in corneal staining with fluorescein	16 weeks
Secondary	Patient symptoms	Change from baseline in patient symptoms as measured by Ocular Surface Disease Index (OSDI)	16 weeks
Secondary	Tear cytokine concentration	Change from baseline in tear cytokine concentration as measured by Raybiotech Human Dry Eye Disease Array Q1	16 weeks