Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparison of Two Steroid Regimens to Prevent Transplant Rejection After Corneal Transplant (DMEK)

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.
ClinicalTrials.gov Identifier: NCT01448213
Recruitment Status : Completed
First Posted : October 7, 2011
Results First Posted : August 25, 2014
Last Update Posted : September 3, 2014
Sponsor:
Information provided by (Responsible Party):
Price Vision Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Conditions Fuchs' Dystrophy
Bullous Keratopathy
Interventions Drug: Prednisolone acetate
Drug: Fluorometholone
Enrollment 264
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution
Hide Arm/Group Description

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Period Title: Overall Study
Started 130 134
Completed 113 112
Not Completed 17 22
Reason Not Completed
Lost to Follow-up             12             10
Adverse Event             4             10
Protocol Violation             1             2
Arm/Group Title Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution Total
Hide Arm/Group Description

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Total of all reporting groups
Overall Number of Baseline Participants 161 164 325
Hide Baseline Analysis Population Description
Baseline characteristics data are reported in units of "eyes" as this presentation is most relevant to the assessments presented in the Outcome Measures module.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 161 participants 164 participants 325 participants
69
(35 to 91)
67
(42 to 94)
68
(35 to 94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 161 participants 164 participants 325 participants
Female
107
  66.5%
105
  64.0%
212
  65.2%
Male
54
  33.5%
59
  36.0%
113
  34.8%
1.Primary Outcome
Title Number of Eyes With Immunologic Graft Rejection Episodes
Hide Description [Not Specified]
Time Frame Within 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution
Hide Arm/Group Description:

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Overall Number of Participants Analyzed 130 134
Overall Number of Units Analyzed
Type of Units Analyzed: Number of Eyes
161 164
Measure Type: Number
Unit of Measure: eyes
2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluorometholone 0.1% Solution, Prednisolone Acetate 1% Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Number of Eyes With Intraocular Pressure (IOP) Elevation
Hide Description Absolute IOP greater than or equal to 24 mm Hg or a relative increase of 10 mm Hg over the baseline preoperative reading.
Time Frame one day, two days, one week, one month, 3 months, 6 months and 12 months after DMEK
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution
Hide Arm/Group Description:

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Overall Number of Participants Analyzed 130 134
Overall Number of Units Analyzed
Type of Units Analyzed: Eyes
161 164
Measure Type: Number
Unit of Measure: eyes
9 32
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Fluorometholone 0.1% Solution, Prednisolone Acetate 1% Solution
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution
Hide Arm/Group Description

Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.

Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.

All-Cause Mortality
Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/130 (0.00%)      0/134 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluorometholone 0.1% Solution Prednisolone Acetate 1% Solution
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/130 (0.00%)      13/134 (9.70%)    
Eye disorders     
Intraocular pressure control problem requiring discontinuation of study drug   0/130 (0.00%)  0 13/134 (9.70%)  13
Indicates events were collected by systematic assessment
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 O. Price, PhD
Organization: Cornea Research Foundation of America
Phone: 317-814-2990
Responsible Party: Price Vision Group
ClinicalTrials.gov Identifier: NCT01448213     History of Changes
Other Study ID Numbers: 2011-0329
First Submitted: October 4, 2011
First Posted: October 7, 2011
Results First Submitted: August 4, 2014
Results First Posted: August 25, 2014
Last Update Posted: September 3, 2014