Trial Outcomes & Findings for Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty (NCT NCT01853696)
NCT ID: NCT01853696
Last Updated: 2015-05-15
Results Overview
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.
COMPLETED
PHASE4
167 participants
from 1 to 12 months after transplant
2015-05-15
Participant Flow
Participant milestones
| Measure |
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
loteprednol etabonate 0.5% gel
|
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
prednisolone acetate 1%
|
|---|---|---|
|
Overall Study
STARTED
|
84
|
83
|
|
Overall Study
COMPLETED
|
78
|
78
|
|
Overall Study
NOT COMPLETED
|
6
|
5
|
Reasons for withdrawal
| Measure |
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
loteprednol etabonate 0.5% gel
|
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
prednisolone acetate 1%
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
Baseline Characteristics
Comparison of Corticosteroid Dosing Regimens After Endothelial Keratoplasty
Baseline characteristics by cohort
| Measure |
Loteprednol
n=84 Participants
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
n=83 Participants
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
n=167 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69 years
n=5 Participants
|
69 years
n=7 Participants
|
69 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
117 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
84 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
166 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
84 participants
n=5 Participants
|
83 participants
n=7 Participants
|
167 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from 1 to 12 months after transplantNumber 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.
Outcome measures
| Measure |
Loteprednol
n=116 eyes
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
n=116 eyes
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%
|
|---|---|---|
|
Intraocular Pressure
|
11 eyes
|
27 eyes
|
SECONDARY outcome
Timeframe: within first year after cornea transplantationRejection 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.
Outcome measures
| Measure |
Loteprednol
n=116 eyes
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
n=116 eyes
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%
|
|---|---|---|
|
Immunologic Graft Rejection Episode
|
0 eyes
|
0 eyes
|
Adverse Events
Loteprednol
Prednisolone Acetate
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Marianne Price, PhD
Cornea Research Foundation of America
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place