Corneal Edema, Corneal Endothelial Dystrophy
Conditions
Brief summary
The purpose of this study is to assess off-label use of loteprednol etabonate 0.25% ophthalmic suspension (Eysuvis) for prevention of immunologic rejection in the first year after Descemet membrane endothelial keratoplasty (DMEK). Topical corticosteroids have long been the mainstay for preventing and treating cornea transplant rejection although none are specifically approved for this purpose. The rates of immunologic rejection episodes and steroid-induced ocular hypertension will be compared with the respective rates observed in earlier studies with prednisolone acetate 1% suspension, loteprednol etabonate 0.5% gel, and fluorometholone 0.1% suspension after DMEK.
Interventions
DRUGloteprednol etabonate 0.25% ophthalmic suspension
tapering dose
Sponsors
Kala Pharmaceuticals, Inc.
Price Vision Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* o At least 18 years of age * Male or female patient who had DMEK within the past 1 to 7 weeks. * Patient is able and willing to administer eye drops. * Patient is able to comprehend and has signed the Informed Consent form. * Patient is likely to complete the 11-month study duration.
Exclusion criteria
* o A history of a previous rejection episode in the study eye * A patient exhibiting intraocular inflammation. * A patient with a known sensitivity to any of the ingredients in the study medications * A patient who has a condition (i.e., UNCONTROLLED systemic disease) or is in a situation which in the investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the patient's participation in the study * A patient with abnormal eyelid function. * A patient that is exhibiting active corneal ulceration, keratitis, or conjunctivitis, or who has a history of herpetic keratitis. * Presence of any ocular disease that would interfere with the evaluation of the study treatment. However, patients with a history of cystoid macular edema, age-related macular degeneration, controlled glaucoma, corneal neovascularization, and other non-interfering comorbidities may be enrolled. * A patient with a history of non-compliance with using prescribed medication. * Patients who are pregnant or planning to become pregnant within the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunologic Rejection | 11 months | incidence of immunologic rejection episodes |
| Steroid-induced Ocular Hypertension | 11 months | incidence of steroid-induced ocular hypertension |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Preventative Treatment Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
loteprednol etabonate 0.25% ophthalmic suspension: tapering dose | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | Preventative Treatment | — |
|---|---|---|
| Age, Continuous | 70 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 70 participants | — |
| Sex: Female, Male Female | 40 Participants | — |
| Sex: Female, Male Male | 30 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 70 |
| other Total, other adverse events | 3 / 70 |
| serious Total, serious adverse events | 0 / 70 |
Outcome results
Primary
Immunologic Rejection
incidence of immunologic rejection episodes
Time frame: 11 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preventative Treatment | Immunologic Rejection | 0 Participants |
Primary
Steroid-induced Ocular Hypertension
incidence of steroid-induced ocular hypertension
Time frame: 11 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Preventative Treatment | Steroid-induced Ocular Hypertension | 1 Participants |