Repository Corticotropin Injection in Keratoconjunctivitis Sicca

• Status: Withdrawn
• Trial end date: 2018-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alabama at Birmingham
• Treatments: Adrenocorticotropic Hormone

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