Repository Corticotropin Injection in Keratoconjunctivitis Sicca
Withdrawn before enrolling · Phase 4
Conditions studied: Keratoconjunctivitis Sicca
In brief
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.
Key facts
- Study ID
- NCT03398018
- Run by
- University of Alabama at Birmingham
- People needed
- 0
- Starts
- 2018-11-01
- Expected to finish
- 2018-11-01
- Last updated by the study team
- 2018-12-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.