Trial Outcomes & Findings for Loteprednol Etabonate 0.25% for Prevention of Cornea Transplant Rejection (NCT NCT05136443)
NCT ID: NCT05136443
Last Updated: 2024-08-14
Results Overview
incidence of immunologic rejection episodes
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
70 participants
Primary outcome timeframe
11 months
Results posted on
2024-08-14
Participant Flow
Participant milestones
| Measure |
Preventative Treatment
Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
loteprednol etabonate 0.25% ophthalmic suspension: tapering dose
|
|---|---|
|
Overall Study
STARTED
|
70
|
|
Overall Study
COMPLETED
|
66
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Preventative Treatment
Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
loteprednol etabonate 0.25% ophthalmic suspension: tapering dose
|
|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Preventative Treatment
n=70 Participants
Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
loteprednol etabonate 0.25% ophthalmic suspension: tapering dose
|
|---|---|
|
Age, Continuous
|
70 years
n=70 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=70 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=70 Participants
|
|
Region of Enrollment
United States
|
70 participants
n=70 Participants
|
PRIMARY outcome
Timeframe: 11 monthsincidence of immunologic rejection episodes
Outcome measures
| Measure |
Preventative Treatment
n=70 Participants
Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
loteprednol etabonate 0.25% ophthalmic suspension: tapering dose
|
|---|---|
|
Immunologic Rejection
|
0 Participants
|
PRIMARY outcome
Timeframe: 11 monthsincidence of steroid-induced ocular hypertension
Outcome measures
| Measure |
Preventative Treatment
n=70 Participants
Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
loteprednol etabonate 0.25% ophthalmic suspension: tapering dose
|
|---|---|
|
Steroid-induced Ocular Hypertension
|
1 Participants
|
Adverse Events
Preventative Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Preventative Treatment
n=70 participants at risk
Loteprednol etabonate ophthalmic suspension 0.25% dosed 4 times daily for 2 months, 3 times daily for one month, twice daily for one month, and once daily until the 1 year postop exam.
loteprednol etabonate 0.25% ophthalmic suspension: tapering dose
|
|---|---|
|
Eye disorders
Steroid induced intraocular pressure elevation
|
1.4%
1/70 • Number of events 1 • 11 months
|
|
Eye disorders
Instillation site discomfort
|
2.9%
2/70 • Number of events 2 • 11 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place