Clinical trial NCT04169061: Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Official title: A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Keratitis
Keywords: Severe or recalcitrant keratitis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2019-11-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We will need about 36 participants for this study.

Volunteers might be able to participate if:

* they have bad noninfectious keratitis
* early treatments failed or were not well tolerated

Participants will be in the study for about 22 weeks:

* 4 weeks for tests to see if the study might be good for them
* 12 weeks of treatment with Acthar gel
* 4 weeks to wean off Acthar gel and follow-up with the doctor


Eligibility criteria: Inclusion Criteria:

* Has severe or recalcitrant keratitis
* Did not respond to, or tolerate, treatment with topical cyclosporine, Lifitegrast, or any immunosuppressant to treat keratitis
* If able to reproduce, agrees to use 2 forms of effective contraception with a partner of the opposite sex for the duration of the study (through Visit 6)
* Has normal eyelids, and protocol-defined physical and medical eye attributes
* Agrees to avoid wearing contact lenses during the trial

Exclusion Criteria:

* Is pregnant or breast-feeding
* Is defined as vulnerable, or is employed by, or related to anyone involved in the study
* Has a medical condition or history that might, per protocol or in the opinion of the investigator, compromise the participant's safety or study analysis

Primary outcomes:
measure: Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea and Cataract Consultants of Arizona
state: Arizona
city: Glendale
country: United States
facility: Global Research Management, Inc.
state: California
city: Newport Beach
country: United States
facility: Eye Research Foundation
state: California
city: Louisville
country: United States
facility: Eye Care Institute
state: Kentucky
city: Raynham
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
city: Nashville
country: United States
facility: Advancing Vision Research, LLC
state: Tennessee
Study officials:
affiliation: Mallinckrodt
name: Global Clinical Leader
role: STUDY_DIRECTOR
References:
citation: Wirta D, McLaurin E, Ousler G, Liu J, Kacmaz RO, Grieco J. Repository Corticotropin Injection (Acthar(R) Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study. Ophthalmol Ther. 2021 Dec;10(4):1077-1092. doi: 10.1007/s40123-021-00400-y. Epub 2021 Oct 20.