Status:
WITHDRAWN
Repository Corticotropin Injection in Keratoconjunctivitis Sicca
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Keratoconjunctivitis Sicca
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
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 f...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03398018
Start Date
November 1 2018
End Date
November 1 2018
Last Update
December 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294