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Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

This study has been completed.
Information provided by (Responsible Party):
Cornea Research Foundation of America Identifier:
First received: May 8, 2013
Last updated: April 29, 2015
Last verified: April 2015
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 Intervention Phase
Fuchs' Dystrophy
Corneal Edema
Drug: loteprednol etabonate
Drug: prednisolone acetate 1%
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty

Resource links provided by NLM:

Further study details as provided by Cornea Research Foundation of America:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 167
Study Start Date: March 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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%


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT01853696

United States, Indiana
Price Vision Group
Indianapolis, Indiana, United States, 46260
Sponsors and Collaborators
Cornea Research Foundation of America
Principal Investigator: Francis W Price, Jr., MD Price Vision Group
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Cornea Research Foundation of America Identifier: NCT01853696     History of Changes
Other Study ID Numbers: 2013-0424
Study First Received: May 8, 2013
Results First Received: April 2, 2015
Last Updated: April 29, 2015

Additional relevant MeSH terms:
Corneal Dystrophies, Hereditary
Fuchs' Endothelial Dystrophy
Corneal Edema
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol Etabonate
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 processed this record on April 26, 2017