Repository Corticotropin Injection in Keratoconjunctivitis Sicca

NCT03398018 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: F00000001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Keratoconjunctivitis Sicca

Keywords

dry eye; corticotropin

Outcome Measures

Primary Outcomes (2)

• Conjunctival hyperemia

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

  16 weeks

• Corneal staining

  Change from baseline in corneal staining with fluorescein

  16 weeks

Secondary Outcomes (2)

• Patient symptoms

  16 weeks

• Tear cytokine concentration

  16 weeks

Other Outcomes (1)

• Needle Fear

  16 weeks

Study Arms (1)

Treatment

EXPERIMENTAL

Treated with repository corticotropin injection

Drug: repository corticotropin injection

Interventions

repository corticotropin injection DRUG

80 units twice per week as a subcutaneous injection

Also known as: HP Acthar Gel

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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®)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Keratoconjunctivitis Sicca; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Eye Diseases; Keratitis; Corneal Diseases; Lacrimal Apparatus Diseases

Study Officials

• Jason J Nichols, OD, MPH, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 12, 2018
• Study Start: November 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: December 14, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)