Impact of Acthar on Everyday Life of Participants With Severe Keratitis

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

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Key information

Conditions

Keratitis Corneal Diseases Eye Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cornea and Cataract Consultants of Arizona, Phoenix, Arizona, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACTHar

Drug

Acthar gel for subcutaneous injection

Other names: Acthar Gel

Primary outcomes

Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12]

Time frame: Week 12

A 12-point score reduction on the 100-point symptom bother module indicates a clinically important reduction of bothersome dry eye symptoms.

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Nov 19, 2019
Registry last updated: Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed