Fuchs' Dystrophy, Corneal Edema
Conditions
Brief summary
Graft rejection has traditionally been one of the leading causes of cornea transplant failure. To help prevent rejection, corticosteroid eye drops are used for an extended period after transplant surgery. The purpose of this study is to compare the efficacy and side effects of different corticosteroid dosing regimens after endothelial keratoplasty (cornea transplant) surgery.
Interventions
Sponsors
Cornea Research Foundation of America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 years of age * Male or female patient who had endothelial keratoplasty procedure 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 one-year course of the study
Exclusion criteria
* 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. * A patient who is concurrently involved in or participated in another randomized clinical trial within 30 days prior to enrollment in this study. * Patients who are pregnant or planning to become pregnant within the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraocular Pressure | from 1 to 12 months after transplant | Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunologic Graft Rejection Episode | within first year after cornea transplantation | Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Loteprednol Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months
loteprednol etabonate | 84 |
| Prednisolone Acetate Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months
prednisolone acetate 1% | 83 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 4 |
| Overall Study | Withdrawal by Subject | 1 | 1 |
Baseline characteristics
| Characteristic | Loteprednol | Total | Prednisolone Acetate |
|---|---|---|---|
| Age, Continuous | 69 years | 69 years | 69 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 84 Participants | 166 Participants | 82 Participants |
| Region of Enrollment United States | 84 participants | 167 participants | 83 participants |
| Sex: Female, Male Female | 56 Participants | 117 Participants | 61 Participants |
| Sex: Female, Male Male | 28 Participants | 50 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 84 | 0 / 83 |
| serious Total, serious adverse events | 0 / 84 | 0 / 83 |
Outcome results
Primary
Intraocular Pressure
Number of eyes in which the absolute intraocular pressure equaled or exceeded 24 mm Hg OR in which there was a relative increase of at least 10 mm Hg over the baseline preoperative reading.
Time frame: from 1 to 12 months after transplant
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol | Intraocular Pressure | 11 eyes |
| Prednisolone Acetate | Intraocular Pressure | 27 eyes |
Secondary
Immunologic Graft Rejection Episode
Rejection episodes were assessed by slit lamp examination and categorized as definite when an endothelial rejection line was detected in a previously clear graft, probable when inflammation (stromal infiltrate, keratic precipitates, cells in the anterior chamber, or ciliary injection) was detected in a previously clear graft without an endothelial rejection line, and possible if central corneal pachymetry increased by 30 microns or more, even if the cornea was clear and no inflammation was detected by slit lamp examination.
Time frame: within first year after cornea transplantation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Loteprednol | Immunologic Graft Rejection Episode | 0 eyes |
| Prednisolone Acetate | Immunologic Graft Rejection Episode | 0 eyes |