Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cornea Research Foundation of America
ClinicalTrials.gov Identifier:
NCT01853696
First received: May 8, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:
  • Change from baseline intraocular pressure [ Time Frame: 1, 3, 6 and 12 months after transplant ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunologic graft rejection episode [ Time Frame: within first year after cornea transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 220
Study Start Date: March 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853696

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

No publications provided

Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT01853696     History of Changes
Other Study ID Numbers: 2013-0424
Study First Received: May 8, 2013
Last Updated: August 4, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Corneal Dystrophies, Hereditary
Corneal Edema
Fuchs' Endothelial Dystrophy
Corneal Diseases
Eye Diseases
Eye Diseases, Hereditary
Genetic Diseases, Inborn
Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Loteprednol etabonate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents

ClinicalTrials.gov processed this record on September 22, 2014