Clinical trial NCT01853696: Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
Official title: Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Fuchs' Dystrophy
Corneal Edema
Lead sponsor: Cornea Research Foundation of America
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Intraocular Pressure
timeFrame: from 1 to 12 months after transplant
Secondary outcomes:
measure: Immunologic Graft Rejection Episode
timeFrame: within first year after cornea transplantation
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
Study officials:
affiliation: Price Vision Group
name: Francis W Price, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price MO, Feng MT, Scanameo A, Price FW Jr. Loteprednol Etabonate 0.5% Gel Vs. Prednisolone Acetate 1% Solution After Descemet Membrane Endothelial Keratoplasty: Prospective Randomized Trial. Cornea. 2015 Aug;34(8):853-8. doi: 10.1097/ICO.0000000000000475.