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Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

Primary Purpose

Fuchs' Dystrophy, Corneal Edema

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
loteprednol etabonate
prednisolone acetate 1%
Sponsored by
Cornea Research Foundation of America
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Fuchs' Dystrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Price Vision Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Loteprednol

Prednisolone acetate

Arm Description

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

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

Outcomes

Primary Outcome Measures

Intraocular Pressure
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
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.

Full Information

First Posted
May 8, 2013
Last Updated
April 29, 2015
Sponsor
Cornea Research Foundation of America
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1. Study Identification

Unique Protocol Identification Number
NCT01853696
Brief Title
Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
Official Title
Prospective, Randomized Comparison of Corticosteroid Dosing Regimens Following Endothelial Keratoplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cornea Research Foundation of America

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fuchs' Dystrophy, Corneal Edema

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
167 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Loteprednol
Arm Type
Active Comparator
Arm Description
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
Arm Title
Prednisolone acetate
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
loteprednol etabonate
Other Intervention Name(s)
Lotemax gel
Intervention Type
Drug
Intervention Name(s)
prednisolone acetate 1%
Primary Outcome Measure Information:
Title
Intraocular Pressure
Description
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.
Time Frame
from 1 to 12 months after transplant
Secondary Outcome Measure Information:
Title
Immunologic Graft Rejection Episode
Description
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.
Time Frame
within first year after cornea transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francis W Price, Jr., MD
Organizational Affiliation
Price Vision Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26020827
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.
Results Reference
derived

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Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

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