Keratitis
Conditions
Keywords
Severe or recalcitrant keratitis
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
Interventions
DRUGActhar
Acthar gel for subcutaneous injection
Sponsors
Mallinckrodt
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Thirty-six participants were enrolled at 8 locations in the United States
Participants by arm
| Arm | Count |
|---|---|
| All Participants Participants receive Acthar Gel administered by a shot under the skin (subcutaneous injection) per study regimen | 36 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Death | 1 |
| Overall Study | Protocol Violation | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 63.6 years STANDARD_DEVIATION 10.17 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 34 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 29 Participants |
| Region of Enrollment United States | 36 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 36 |
| other Total, other adverse events | 2 / 36 |
| serious Total, serious adverse events | 1 / 36 |
Outcome results
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.
Time frame: Week 12
Population: Participants with non-missing baseline data
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| All Participants | 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 |