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Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty

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ClinicalTrials.gov Identifier: NCT01853696
Recruitment Status : Completed
First Posted : May 15, 2013
Results First Posted : April 30, 2015
Last Update Posted : May 15, 2015
Sponsor:
Information provided by (Responsible Party):
Cornea Research Foundation of America

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Prevention
Conditions Fuchs' Dystrophy
Corneal Edema
Interventions Drug: loteprednol etabonate
Drug: prednisolone acetate 1%
Enrollment 167
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Loteprednol Prednisolone Acetate
Hide Arm/Group 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

loteprednol etabonate 0.5% gel

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

prednisolone acetate 1%

Period Title: Overall Study
Started 84 83
Completed 78 78
Not Completed 6 5
Reason Not Completed
Withdrawal by Subject             1             1
Lost to Follow-up             5             4
Arm/Group Title Loteprednol Prednisolone Acetate Total
Hide Arm/Group 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

loteprednol etabonate

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

prednisolone acetate 1%

Total of all reporting groups
Overall Number of Baseline Participants 84 83 167
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 84 participants 83 participants 167 participants
69
(22 to 88)
69
(22 to 89)
69
(22 to 89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
Female
56
  66.7%
61
  73.5%
117
  70.1%
Male
28
  33.3%
22
  26.5%
50
  29.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 84 participants 83 participants 167 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
   1.2%
1
   0.6%
White
84
 100.0%
82
  98.8%
166
  99.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 84 participants 83 participants 167 participants
84 83 167
1.Primary Outcome
Title Intraocular Pressure
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loteprednol Prednisolone Acetate
Hide Arm/Group 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

loteprednol etabonate 0.5% gel

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

prednisolone acetate 1%

Overall Number of Participants Analyzed 84 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
116 116
Measure Type: Number
Unit of Measure: eyes
11 27
2.Secondary Outcome
Title Immunologic Graft Rejection Episode
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Loteprednol Prednisolone Acetate
Hide Arm/Group 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

loteprednol etabonate 0.5% gel

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

prednisolone acetate 1%

Overall Number of Participants Analyzed 84 83
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
116 116
Measure Type: Number
Unit of Measure: eyes
0 0
Time Frame 11 months study duration
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Loteprednol Prednisolone Acetate
Hide Arm/Group 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

loteprednol etabonate 0.5% gel

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

prednisolone acetate 1%

All-Cause Mortality
Loteprednol Prednisolone Acetate
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Loteprednol Prednisolone Acetate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/83 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Loteprednol Prednisolone Acetate
Affected / at Risk (%) Affected / at Risk (%)
Total   0/84 (0.00%)   0/83 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marianne Price, PhD
Organization: Cornea Research Foundation of America
Phone: 317-814-2990
Responsible Party: Cornea Research Foundation of America
ClinicalTrials.gov Identifier: NCT01853696     History of Changes
Other Study ID Numbers: 2013-0424
First Submitted: May 8, 2013
First Posted: May 15, 2013
Results First Submitted: April 2, 2015
Results First Posted: April 30, 2015
Last Update Posted: May 15, 2015