Impact of Acthar on Everyday Life of Participants With Severe Keratitis

Phase 4

Completed

• Conditions: Keratitis
• Interventions: Drug: Acthar

• Registration Number: NCT04169061
• Lead Sponsor: Mallinckrodt

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-13
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-18
• Study First Posted: 2019-11-19
• Primary Completion: 2020-11-09
• Study Completion: 2020-12-07
• Status Verified: 2021-07
• Results First Submitted: 2021-07-07
• Results First Submitted QC: 2021-07-27
• Last Update Submitted: 2021-07-27
• Results First Posted: 2021-08-18
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	Acthar	Participants receive: * a shot of Acthar (80 units) under the skin twice a week for 12 weeks * a shot of Acthar (40 units) twice a week for 2 weeks * a shot of Acthar (40 units) once a week for 2 more weeks At each visit they will have medical tests and answer questions about their symptoms.

Primary Outcome Measures

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

Trial Locations

Locations (9)

Cornea and Cataract Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Global Research Management, Inc.; 🇺🇸 Glendale, California, United States

Eye Research Foundation; 🇺🇸 Newport Beach, California, United States

Eye Care Institute; 🇺🇸 Louisville, Kentucky, United States

Andover Eye Associates; 🇺🇸 Raynham, Massachusetts, United States

Vita Eye Clinic; 🇺🇸 Shelby, North Carolina, United States

Scott & Christie and Associates, PC; 🇺🇸 Cranberry Township, Pennsylvania, United States

Total Eye Care, P.A.; 🇺🇸 Memphis, Tennessee, United States

Advancing Vision Research, LLC; 🇺🇸 Nashville, Tennessee, United States