Status:
COMPLETED
Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
Lead Sponsor:
Cornea Research Foundation of America
Conditions:
Fuchs' Dystrophy
Corneal Edema
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 surg...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT01853696
Start Date
March 1 2013
End Date
January 1 2015
Last Update
May 15 2015
Active Locations (1)
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1
Price Vision Group
Indianapolis, Indiana, United States, 46260