Neurotrophic Keratitis
Conditions
Keywords
Stage 1 Neurotrophic Keratitis, Corneal Disease, Ocular Disease
Brief summary
This study is to evaluate the safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK).
Detailed description
This is a 8-week, multicenter, open label, prospective study with 24 weeks of follow-up to evaluate safety and efficacy of OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution in patients with Stage 1 neurotrophic keratitis (NK)
Interventions
DRUGcenegermin-bkbj
OXERVATE® 0.002% (20 mcg/mL) cenegermin-bkbj ophthalmic solution administered as one drop in the affected eye(s), 6 times a day at 2-hour intervals for 8 weeks, in patients with Stage 1 neurotrophic keratitis.
Sponsors
Dompé US
Dompé Farmaceutici S.p.A
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
1. Male or female aged ≥ 18 years. 2. Patients with Stage 1 NK defined by the Mackie criteria
Exclusion criteria
1. Evidence of an active ocular infection (bacterial, viral, protozoal) in either eye. 2. Have current or history of conditions that may confound the study data including but not limited to Ocular Cicatricial Pemphigoid (OCP), Graft Versus Host Disease (GVHD), neuromyelitis optica, uncontrolled dry eye, and Steven Johnson's syndrome. 3. History of severe systemic allergy or severe ocular allergy (including seasonal conjunctivitis expected during the subject's participation in the trial) or chronic conjunctivitis and/or keratitis other than dry eye disease. 4. Patients with severe vision loss with no potential for visual improvement in the study eye, in the opinion of the investigator, or if the subject is deemed legally blind. 5. Ocular surgery or elective ocular surgery expected during participation in the trial. 6. Patients with eyelid abnormality that may alter eyelid function including but not limited to Blepharospasm, Cerebrovascular accident, entropion, ectropion, floppy lid syndrome.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Epithelial Healing | Week 8 | Percentage of patients who experienced corneal epithelial healing. Corneal epithelial healing was defined by the central reading center as the absence of persistent epithelial staining abnormalities related to disease. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj cenegermin-bkbj: Cenegermin-bkbj ophthalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks | 37 |
| Total | 37 |
Baseline characteristics
| Characteristic | OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants |
| Age, Continuous | 64.6 years STANDARD_DEVIATION 11.89 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race Asian | 1 Participants |
| Race/Ethnicity, Customized Race Black or African American | 3 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants |
| Race/Ethnicity, Customized Race White | 32 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 28 Participants |
| Sex: Female, Male Male | 9 Participants |
| Treated Eyes Participants with Treated Non-Study Eye | 15 participants |
| Treated Eyes Participants with Treated Study Eye | 37 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 37 | 1 / 37 |
| other Total, other adverse events | 22 / 37 | 13 / 37 | 16 / 37 |
| serious Total, serious adverse events | 1 / 37 | 0 / 37 | 7 / 37 |
Outcome results
Primary
Corneal Epithelial Healing
Percentage of patients who experienced corneal epithelial healing. Corneal epithelial healing was defined by the central reading center as the absence of persistent epithelial staining abnormalities related to disease.
Time frame: Week 8
Population: Full Analysis Set (FAS) - All enrolled patients who received at least one dose of the study drug. The FAS was used both for efficacy and safety analyses. Observed cases (n=33)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj | Corneal Epithelial Healing | No | 5 Participants |
| OXERVATE® 0.002% (20 mcg/mL) Cenegermin-bkbj | Corneal Epithelial Healing | Yes | 28 Participants |