Impact of Acthar on Everyday Life of Participants With Severe Keratitis

Keratitis Clinical Trial

Official title:

A Multicenter, Open-label Study to Assess the Efficacy and Safety of Acthar® Gel in Subjects With Severe Keratitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04169061
• Other study ID #: MNK14084113
• Status: Completed
• Phase: Phase 4
• Start date: November 13, 2019
• Est. completion date: December 7, 2020

Study information

• Verified date: July 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 7, 2020
• Est. primary completion date: November 9, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Keratitis

Intervention

Drug:
• Acthar
Acthar gel for subcutaneous injection

Locations

Country	Name	City	State
United States	Scott & Christie and Associates, PC	Cranberry Township	Pennsylvania
United States	Global Research Management, Inc.	Glendale	California
United States	Eye Care Institute	Louisville	Kentucky
United States	Total Eye Care, P.A.	Memphis	Tennessee
United States	Advancing Vision Research, LLC	Nashville	Tennessee
United States	Eye Research Foundation	Newport Beach	California
United States	Cornea and Cataract Consultants of Arizona	Phoenix	Arizona
United States	Andover Eye Associates	Raynham	Massachusetts
United States	Vita Eye Clinic	Shelby	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]	A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.	Week 12