Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty

Conditions
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Fuchs' Dystrophy, Corneal Edema

Intervention / Treatment
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* Drug: loteprednol etabonate
* Drug: prednisolone acetate 1%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Loteprednol<br>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 | Drug: loteprednol etabonate<br> <br> * Other names: Lotemax gel;|
| Active Comparator: Prednisolone acetate<br>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 | Drug: prednisolone acetate 1%<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | from 1 to 12 months after transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | within first year after cornea transplantation |