Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

Cornea Research Foundation of America

Status and phase: Completed; Phase 4

Conditions: Corneal Edema; Fuchs' Dystrophy

Treatments: Drug: loteprednol etabonate; Drug: prednisolone acetate 1%

Study type: Interventional

Funder types: Other

Identifiers

NCT01853696

2013-0424

Details and patient eligibility

About

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.

Enrollment: 167 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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167 participants in 2 patient groups

Loteprednol

Active Comparator group

Description:

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

Treatment:

Drug: loteprednol etabonate

Prednisolone acetate

Active Comparator group

Description:

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

Treatment:

Drug: prednisolone acetate 1%