Phase 4
Completed N=36
Impact of Acthar on Everyday Life of Participants With Severe Keratitis
Source: ClinicalTrials.gov NCT04169061 ↗Enrolled (actual)
36
Serious AEs
2.8%
Results posted
Aug 2021
Primary outcomePrimary: Number of Participants Who Improved on the Impact of Dry Eye on Everyday Life (IDEEL) Scale [Using the Symptom Bother Module at Week 12] — 17 Participants
◆ Published Evidence
Emerging
12citations · ~2 / year
Repository Corticotropin Injection (Acthar<sup>®</sup> Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study.
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
Linked Publications
-
Repository Corticotropin Injection (Acthar<sup>®</sup> Gel) for Refractory Severe Noninfectious Keratitis: Efficacy and Safety from a Phase 4, Multicenter, Open-Label Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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] |
17 | — |
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
Data sourced from ClinicalTrials.gov (NCT04169061) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.