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Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01853696
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : April 30, 2015
Last Update Posted : May 15, 2015
Information provided by (Responsible Party):
Cornea Research Foundation of America

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.

Condition or disease Intervention/treatment Phase
Fuchs' Dystrophy Corneal Edema Drug: loteprednol etabonate Drug: prednisolone acetate 1% Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 167 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty
Study Start Date : March 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Arm Intervention/treatment
Active Comparator: 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
Drug: loteprednol etabonate
Other Name: Lotemax gel

Active Comparator: 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
Drug: prednisolone acetate 1%

Primary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 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 Outcome Measures :
  1. Immunologic Graft Rejection Episode [ Time Frame: 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01853696

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United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Cornea Research Foundation of America
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Principal Investigator: Francis W Price, Jr., MD Price Vision Group
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Cornea Research Foundation of America Identifier: NCT01853696    
Other Study ID Numbers: 2013-0424
First Posted: May 15, 2013    Key Record Dates
Results First Posted: April 30, 2015
Last Update Posted: May 15, 2015
Last Verified: April 2015
Additional relevant MeSH terms:
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Corneal Edema
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases
Corneal Dystrophies, Hereditary
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Loteprednol Etabonate
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Anti-Allergic Agents